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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, liquid
510(k) Number K982116
Device Name AQUACEL HYDROFIBER WOUND DRESSING
Applicant
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
100 HEADQUARTERS PARK DR.
SKILLMAN,  NJ  08558
Applicant Contact AMEER ALLY
Correspondent
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
100 HEADQUARTERS PARK DR.
SKILLMAN,  NJ  08558
Correspondent Contact AMEER ALLY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/16/1998
Decision Date 09/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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