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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 K974205
Device Name KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
Applicant
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
100 HEADQUARTERS PARK DR.
SKILLMAN,  NJ  08558
Applicant Contact ADRIENNE MCNALLY
Correspondent
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
100 HEADQUARTERS PARK DR.
SKILLMAN,  NJ  08558
Correspondent Contact ADRIENNE MCNALLY
Regulation Number880.5090
Classification Product Code
KMF  
Date Received11/10/1997
Decision Date 02/06/1998
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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