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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K080383
FOIA Releasable 510(k) K080383
Device Name AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
Applicant
Convatec, A Division of E.R. Squibb & Sons, LLC
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact MARILYN KONICKY
Correspondent
Convatec, A Division of E.R. Squibb & Sons, LLC
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact MARILYN KONICKY
Classification Product Code
FRO  
Date Received02/12/2008
Decision Date 05/02/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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