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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 K901155
Device Name DUODERM* CONTROL GEL FORMULA BORDER DRESSING
Applicant
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
P.O. BOX 4000
PRINCETON,  NJ  08540
Applicant Contact B DREYLING
Correspondent
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
P.O. BOX 4000
PRINCETON,  NJ  08540
Correspondent Contact B DREYLING
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/13/1990
Decision Date 04/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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