AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING

Dressing, Wound, Drug

CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, LLC.

The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons, Llc. with the FDA for Aquacel Hydrofiber Dressing And Aquacel Ag With Hydrofiber Silver Impregnated Antimicrobial Dressing.

Pre-market Notification Details

Device IDK063271
510k NumberK063271
Device Name:AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING
ClassificationDressing, Wound, Drug
Applicant CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, LLC. 200 HEADQUARTERS PARK DR. Skillman,  NJ  08558
ContactMarilyn Konicky
CorrespondentMarilyn Konicky
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, LLC. 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 Received2006-10-30
Decision Date2007-04-16
Summary:summary

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