AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING

Dressing, Wound, Drug

CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C.

The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons, L.l.c. with the FDA for Aquacel Hydrofiber Wound Dressing And Ag Hydrofiber Dressing.

Pre-market Notification Details

Device IDK080383
510k NumberK080383
Device Name:AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
ClassificationDressing, Wound, Drug
Applicant CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. 200 HEADQUARTERS PARK DR. Skillman,  NJ  08558
ContactMarilyn Konicky
CorrespondentMarilyn Konicky
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. 200 HEADQUARTERS PARK DR. Skillman,  NJ  08558
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-02-12
Decision Date2008-05-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00768455145621 K080383 000
10768455106742 K080383 000

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