Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed...
Transcript of Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed...
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
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TABLE OF CONTENTS
Special 510(k)
HEALICOIL PK Suture Anchor
(formerly Next Generation Fully Threaded Suture Anchor)
Title Page(s)
SECTION I Required Elements for all 510(k) submissions
Cover Letter
Medical Device User Fee Cover Sheet 2
CDRH Submission Cover Sheet 3
Certification of Compliance with ClinicalTrials.gov Data Bank 8
Table of Contents 9
Screening Checklist For All Premarket Notification [510(k)] Submissions 10
Standards Data Report for 510(K)s - FDA 3654 14
Premarket Notification Truthful and Accurate Statement Certification 20
Indications for Use 22
SECTION II Required Elements for all 510(k) submissions: General Information
A. Device Name: trade, common or proprietary and classification name 23
B. Submitter Information 23
C. Establishment Registration Number(s) 23
D. Device Classification: Regulation Number and Regulatory Status 23
E. Performance Standards 23
SECTION III Required Elements for all 510(k) submissions: Device Modification A. Introduction 24
B. Unmodified Predicate Device 25
C. Description of Modification(s) 25
D. Design Control Activities Summary 28
a. Risk Analysis Method
b. Verification Validation Activities
E. Substantial Equivalence Comparison 29
SECTION IV 510(k) Summary of Safety and Effectiveness 31
Exhibit A Engineering Drawings
Exhibit B Current Labeling
Exhibit C Animal Study Report:
Exhibit D Report
Exhibit E Declaration of Conformity with Design Controls
9
(b)(4)
(b)(4)
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SCREENING CHECKLIST
Special 510(k) Do Sections 1 and 2
Abbreviated 510(k) Do Sections 1, 3 and 4
Traditional 510(k) Do Sections 1 and 4
Section 1: Required Elements for All Types of 510(k) submissions:
Present Inadequate or
Missing
Cover letter, containing the elements listed on page 3-2 of the Premarket
Notification [510)] Manual.
Section I
Table of Contents. Section I,
Page 9
Truthful and Accurate Statement. Section I,
Page 20
Device’s Trade Name, Device’s Classification Name and Establishment
Registration Number.
Section II,
Page 23
Device Classification Regulation Number and Regulatory Status (Class I,
Class II, Class III or Unclassified).
Section II,
Page 23
Proposed Labeling including the material listed on page 3-4 of the Premarket
Notification [510)] Manual.
Exhibit B
Statement of Indications for Use that is on a separate page in the premarket
submission.
Section I,
Page 22
Substantial Equivalence Comparison, including comparisons of the new
device with the predicate in areas that are listed on page 3-4 of the Premarket
Notification [510)] Manual.
Section III,
Page 29
510(k) Summary or 510(k) Statement. Section IV,
Page 31
Description of the device (or modification of the device) including diagrams,
engineering drawings, photographs or service manuals.
Section III &
Exhibit A
Identification of legally marketed predicate device. * Section III,
Page 25
Compliance with performance standards. * [See Section 514 of the Act and
21 CFR 807.87 (d).]
N/A
Class III Certification and Summary. ** N/A
Financial Certification or Disclosure Statement for 510(k) notifications with a
clinical study. * [See 21 CFR 807.87 (i)]
N/A
510(k) Kit Certification *** N/A
* - May not be applicable for Special 510(k)s.
** - Required for Class III devices, only.
*** - See pages 3-12 and 3-13 in the Premarket Notification [510)] Manual and the Convenience
Kits Interim Regulatory Guidance.
10
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Section 2: Required Elements for a SPECIAL 510(k) submission:
Present Inadequate or
Missing
Name and 510(k) number of the sponsor’s own, unmodified predicate device. Section III,
Page 25
A description of the modified device and a comparison to the sponsor’s
predicate device.
Section III,
Pages 25 - 29
A statement that the intended use(s) and indications of the modified device,
as described in its labeling, are the same as the intended uses and indications
for the sponsor’s unmodified predicate device.
Section III,
Page 29
A statement that the modification has not altered the fundamental technology
of the sponsor’s predicate device.
Section III,
Page 29
A Design Control Activities Summary that includes the following elements
(a-e):
(no entry here) (no entry here)
a. Identification of Risk Analysis method(s) used to assess the impact of the
modification on the device and its components, and the results of the analysis.
Section III,
Page 28
b. Based on the Risk Analysis, an identification of the required verification
and validation activities, including the methods or tests used and the
acceptance criteria to be applied.
Section III,
Page 28
c. A Declaration of Conformity with design controls that includes the
following statements:
Exhibit E
A statement that, as required by the risk analysis, all verification and
validation activities were performed by the designated individual(s) and
the results of the activities demonstrated that the predetermined
acceptance criteria were met. This statement is signed by the individual
responsible for those particular activities.
Exhibit E
A statement that the manufacturing facility is in conformance with the
design control procedure requirements as specified in 21 CFR 820.30
and the records are available for review. This statement is signed by the
individual responsible for those particular activities.
Exhibit E
11
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Section 3: Required Elements for an ABBREVIATED 510(k)* submission:
Present Inadequate or
Missing
For a submission, which relies on a guidance document and/or special
control(s), a summary report that describes how the guidance and/or special
control(s) was used to address the risks associated with the particular device
type. (If a manufacturer elects to use an alternate approach to address a
particular risk, sufficient detail should be provided to justify that approach.)
N/A (Special)
For a submission, which relies on a recognized standard, a declaration of
conformity , For a listing of the required elements of a declaration of
conformity, SEE Required Elements for a Declaration of Conformity to a
Recognized Standard.
For a submission, which relies on a recognized standard without a declaration
of conformity, a statement that the manufacturer intends to conform to a
recognized standard and that supporting data will be available before
marketing the device.
For a submission, which relies on a non-recognized standard that has been
historically accepted by FDA, a statement that the manufacturer intends to
conform to a recognized standard and that supporting data will be available
before marketing the device.
For a submission, which relies on a non-recognized standard that has not
been historically accepted by FDA, a statement that the manufacturer intends
to conform to a recognized standard and that supporting data will be available
before marketing the device and any additional information requested by the
reviewer in order to determine substantial equivalence.
Any additional information, which is not covered by the guidance document,
special control, recognized standard and/or non-recognized standard, in order
to determine substantial equivalence.
- When completing the review of an abbreviated 510(k), please fill out an Abbreviated Standards Data
Form and list all the guidance documents, special controls, recognized standards and/or non-
recognized standards, which were noted by the sponsor.
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Section 4: Additional Requirements for ABBREVIATED and TRADITIONAL
510(k) submissions (If Applicable):
Present Inadequate or
Missing
a) Biocompatibility data for all patient-contacting materials, OR certification
of identical material/formulation:
N/A (Special)
b) Sterilization and expiration dating information:
i) sterilization process
ii) validation method of sterilization process
iii) SAL
iv) packaging
v) specify pyrogen free
vi) ETO residues
vii) radiation dose
viii) Traditional method or non traditional method
c) Software Documentation:
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Indications for Use
510(k) Number (if known): ___________________________________________
Device Name: HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture
Anchor)
Indications For Use:
The HEALICOIL PK Suture Anchor (formerly Smith & Nephew Next Generation Fully
Threaded PEEK Suture Anchor) is intended for use for the reattachment of soft tissue to bone for
the following indications:
Shoulder:
Bankart lesion repairs
Slap lesion repairs
Capsular shift or capsulolabral
reconstructions
Acromioclavicular separation repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis
Foot & Ankle:
Hallux valgus repairs
Medial or lateral instability
repairs/reconstructions
Achilles tendon repairs/reconstruction
Midfoot reconstructions
Metatarsal ligament/tendon
repairs/reconstructions
Knee:
Extra-capsular repairs:
Medial collateral ligament
Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon repairs:
Vastus medialis obliquous advancement
Iliotibial band tenodesis.
Elbow:
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Biceps tendon reattachment
Hip: Gluteal tendon repairs
- Gluteus medius and gluteus minimus repair
Prescription Use ___x___ AND/OR Over-The-Counter Use ______
(Per 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
22
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SECTION II
Required Elements for all 510(k) submissions: General Information
A. Device Name (Unmodified):
Device Trade Name HEALICOIL PK Suture Anchor
(formerly Next Generation Fully Threaded
Suture Anchor)
Common/Classification Name Fastener, fixation, non-degradable, soft tissue
B. Submitter Information:
Company Name Smith & Nephew, Inc., Endoscopy Division
Address 150 Minuteman Road, Andover, MA 01810
Contact Elizabeth Lavelle,
Senior Regulatory Affairs Specialist
C. Establishment Registration Number(s):
Owner/Operator Name Smith & Nephew, Inc. Endoscopy Division
Address 150 Minuteman Road, Andover, MA 01810
Establishment Registration # ER# 3003604053
Owner Operator # 1216828
Manufacturing Site
Address
Establishment Registration #
Owner Operator #
Sterilization Site Name
Address
Establishment Registration #
D. Device Classification: Regulation Number and Regulatory Status
Class Class II
Regulation Number 21 CFR §888.3040
Procode MBI
Panel Orthopedics
E. Performance Standards
There are no known performance standards or special controls promulgated under
section 514 of the Act for this device.
23
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SECTION III
Required Elements for all 510(k) submissions: Device Modification
A. Introduction
Smith and Nephew, Inc. has a long history marketing suture anchors for the
reattachment of soft tissue to bone. These anchors are available in a range of
materials, both permanent and absorbable, and include various size and design
configurations to meet the needs of orthopedic surgeons.
The purpose of this premarket notification is to gain clearance for marketing
claims for Smith & Nephew’s Next Generation Fully Threaded PEEK Suture
Anchor (now named the HEALICOIL PK Suture Anchor) regarding bone in-
growth.
The HEALICOIL PK Suture Anchor (K110545) consists of a non-absorbable
anchor manufactured from PEEK (polyetheretherketone), loaded with up to three
strands of suture and pre-assembled onto a stainless steel insertion device. One of
the main design features of HEALICOIL PK Suture Anchor is its open core
architecture (Figure 1). The integrated inserter/awl extends through the full
length of the anchor and beyond the distal end. Accessories specific to the
HEALICOIL PK Suture Anchors, including spade tip drills and awl-dilators,
which are recommended for hole preparation per the Instructions for Use.
FIGURE 1. Photo and Illustrations of the HEALICOIL PK (formerly Next
Generation Fully Threaded) Suture Anchor
24
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Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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TABLE 2. Design Verification Activity
E. Substantial Equivalence Comparison
The subject of this 510(k), the HEALICOIL PK Suture Anchor, is substantially
equivalent to the Next Generation Fully Threaded Suture Anchor (K110545)
because there are no changes to the design, material, fundamental technology,
intended use, or indications for use (other than minor modifications made to
dimensions and labeling documented internally per FDA guidance document
K97-1, “Deciding When to Submit a 510(k) for a Change to an Existing Device.”)
Please refer to Table 3 below.
The purpose of this submission is to obtain clearance for bone in-growth claims to
be used in Smith & Nephew promotional materials, supported by a 12 week in
vivo ovine study.
29
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TABLE 3. Comparison of Proposed Device to Predicate Device
Characteristic Predicate Device K110545
NGFTSA PK
(now called HEALICOIL
PK Suture Anchor)
Subject of this 510(k)
HEALICOIL PK
Suture Anchor
(Same)
Indications for
Use
Reattachment of soft tissue
to bone in shoulder, foot,
knee, ankle, elbow, and hip
Same
Outer Diameter 4.5 and 5.5mm Same
Sterilization
Method
Ethylene Oxide Same
Material PEEK Same
Profile Same
How Supplied Anchor preloaded with # 2
suture and preassembled
onto insertion device
Same
Shelf Life 5 years Same
Thread design Single lead thread Same
Insertion
Technique
Screw-in Same
Labeling claims Mean fixation strength is
greater than 24.48N (5.465
lbf) in 5, 45/15, and 30 pcf
bone block densities.
Please refer to K110545
for all values.
Same plus the following
bone in-growth claims
supported by a sheep
study:
The open architecture of the
HEALICOIL PK Suture
Anchor allows for new bone
to fill the fenestrations
between threads and into the
central channel.
The Smith and Nephew
HEALICOIL PK Suture
Anchor contained 63% of the
bone volume of control bone
by 12 weeks post-
implantation.
30
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31
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32
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EXHIBIT A
Engineering Drawings
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(b)(4) Engineering Drawings
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(b)(4) Engineering Drawings
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(b)(4) Engineering Drawings
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(b)(4) Engineering Drawings
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EXHIBIT B Current Labeling
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EXHIBIT C
Animal Study Report: “Evaluation of a New Suture Anchor Design in an Ovine
Bone Defect Model: A Pilot Study
(b)(4)
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
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(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 83: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/83.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 84: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/84.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 87: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/87.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 89: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/89.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 92: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/92.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 93: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/93.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 94: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/94.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 95: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/95.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 96: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/96.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 97: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/97.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 98: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/98.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 99: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/99.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 100: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/100.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 101: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/101.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 102: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/102.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 103: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/103.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 104: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/104.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 105: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/105.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 106: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/106.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 107: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/107.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 108: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/108.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 109: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/109.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 110: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/110.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 111: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/111.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 112: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/112.jpg)
EXHIBIT D
Report (b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Page 1 of 5
Smith & Nephew Research Centre Work Report
(b)(4), (b)(6)
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 115: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/115.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 116: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/116.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 117: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/117.jpg)
(b)(4) Testing
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 118: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/118.jpg)
EXHIBIT E
Declaration of Conformity with Design Controls
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 120: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/120.jpg)
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 121: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/121.jpg)
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 122: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/122.jpg)
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 123: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/123.jpg)
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 124: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/124.jpg)
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 125: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/125.jpg)
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 126: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/126.jpg)
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 127: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/127.jpg)
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 128: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/128.jpg)
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
![Page 129: Records processed under FOIA Request # 2017-10380, released … · 2018-08-30 · Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18 Questions? Contact](https://reader036.fdocuments.in/reader036/viewer/2022063005/5fb3e5abd315d06e9779c1f9/html5/thumbnails/129.jpg)
Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Records processed under FOIA Request # 2017-10380, released by CDRH on 8-30-18
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118