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White Paper: Lance™ Safety Heelstick · 2016. 7. 25. · developed a streamlined 510(k) process for modifications to a device cleared under 510(k), called the Special 510(k). The

White Paper: Lance™ Safety Heelstick · 2016. 7. 25. · developed a streamlined 510(k) process for modifications to a device cleared under 510(k), called the Special 510(k). The

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION … · 2019. 3. 13. · 1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K183446 B. Purpose

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION … · 2019. 3. 13. · 1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K183446 B. Purpose

510(k) Format Guidance, Including Standards Form, and Extensions Clinical Trial Form and 510(k).pdf

510(k) Format Guidance, Including Standards Form, and Extensions Clinical Trial Form and 510(k).pdf

10 510(k) Summary - Food and Drug Administration › cdrh_docs › pdf13 › K131936.pdf · 10 510(k) Summary JUL 3 12013 510(k) Summary BioFire Diagnostics, Inc. ... Time Required

10 510(k) Summary - Food and Drug Administration › cdrh_docs › pdf13 › K131936.pdf · 10 510(k) Summary JUL 3 12013 510(k) Summary BioFire Diagnostics, Inc. ... Time Required

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY · 2016-08-05 · 1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION . DECISION SUMMARY . A. 510(k) Number: K160729 B. Purpose

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY · 2016-08-05 · 1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION . DECISION SUMMARY . A. 510(k) Number: K160729 B. Purpose

E-caio 510(k)

E-caio 510(k)

510(k) Substantial Equivalence Determination Decision ...

510(k) Substantial Equivalence Determination Decision ...

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION · 2017-06-07 · 1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170652 B. Purpose for Submission:

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION · 2017-06-07 · 1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K170652 B. Purpose for Submission:

510(k) Submissions Recent Experience and Perspectives

510(k) Submissions Recent Experience and Perspectives

The 510(k) Program: Evaluating Substantial Equivalence … · The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and

The 510(k) Program: Evaluating Substantial Equivalence … · The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and

510(k) Process:

510(k) Process:

Pulmonary Alveolus - Copy

Pulmonary Alveolus - Copy

510 K Working Group Volume II

510 K Working Group Volume II

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION ... · 1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM . ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION ... · 1 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM . ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k

The 510(k) Program: Evaluating Substantial … 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration

The 510(k) Program: Evaluating Substantial … 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. B. C. · PDF file · 2014-06-051 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY . A. 510(k) Number:

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. B. C. · PDF file · 2014-06-051 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY . A. 510(k) Number:

510(k) from page 1 - aaos.org 510(k) programMost require Premarket Notification 510(k). and those of products approved through the PMA pathway to determine if

510(k) from page 1 - aaos.org 510(k) programMost require Premarket Notification 510(k). and those of products approved through the PMA pathway to determine if

510(k) Summary - Food and Drug AdministrationSonoScape Company Limited 510(k) Submission 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted

510(k) Summary - Food and Drug AdministrationSonoScape Company Limited 510(k) Submission 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted

510(k) Summary MAY 16 2014 LLC - Food and Drug …510(k) Summary 510(k) -ARlOQO Series K131096 Arobella Medical, LLC 807.92(a)(4) Device Description The ARi 000 Ultrasonic Wound Therapy

510(k) Summary MAY 16 2014 LLC - Food and Drug …510(k) Summary 510(k) -ARlOQO Series K131096 Arobella Medical, LLC 807.92(a)(4) Device Description The ARi 000 Ultrasonic Wound Therapy

Diagnostic/Biomarker Development Breakout...• Abbreviated 510(k): 510(k) guidance/special controls or recognized standard available • De novo 510(k): no substantial equivalent

Diagnostic/Biomarker Development Breakout...• Abbreviated 510(k): 510(k) guidance/special controls or recognized standard available • De novo 510(k): no substantial equivalent