AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER

Dressing, Wound, Drug

CONVATEC INC

The following data is part of a premarket notification filed by Convatec Inc with the FDA for Aquacel Ag Extra Hydrofiber Dressing With Silver And Strengthening Fiber.

Pre-market Notification Details

Device IDK121275
510k NumberK121275
Device Name:AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
ClassificationDressing, Wound, Drug
Applicant CONVATEC INC 200 HEADQUARTERS PARK DRIVE Skillman,  NJ  08558
ContactKatrina Fiedler
CorrespondentKatrina Fiedler
CONVATEC INC 200 HEADQUARTERS PARK DRIVE Skillman,  NJ  08558
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2012-04-27
Decision Date2012-07-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00768455127481 K121275 000
00768455145645 K121275 000
00768455145652 K121275 000
00768455145669 K121275 000
00768455145676 K121275 000
00768455145683 K121275 000
00768455127375 K121275 000
00768455127405 K121275 000
00768455127436 K121275 000
00768455127450 K121275 000
00768455145638 K121275 000

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