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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K935948
Device Name CONVATEC TWO PIECE ABSORBENT DRESSING SYSTEM
Applicant
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Applicant Contact ADRIENNE MCNALLY
Correspondent
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Correspondent Contact ADRIENNE MCNALLY
Regulation Number880.5240
Classification Product Code
KGX  
Subsequent Product Code
KMF  
Date Received12/13/1993
Decision Date 03/01/1994
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
Predetermined Change
Control Plan Authorized		 No
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