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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 K954918
Device Name COMBIDERM ACD
Applicant
Convatec, A Bristol-Myers Squibb Co.
P.O. Box Cn 5254
Princeton,  NJ  08543
Applicant Contact MCFORD ZAMORE
Correspondent
Convatec, A Bristol-Myers Squibb Co.
P.O. Box Cn 5254
Princeton,  NJ  08543
Correspondent Contact MCFORD ZAMORE
Regulation Number880.5090
Classification Product Code
KMF  
Date Received10/26/1995
Decision Date 12/26/1995
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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