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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 K974823
Device Name NONWOVEN DRESSING
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 Received12/24/1997
Decision Date 02/20/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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