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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 K090254
Device Name SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)
Applicant
Convatec, A Division of E.R. Squibb & Sons, LLC
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact PATRICIA KEARINS
Correspondent
Convatec, A Division of E.R. Squibb & Sons, LLC
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact PATRICIA KEARINS
Classification Product Code
FRO  
Date Received02/02/2009
Decision Date 09/04/2009
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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