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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solvent, Adhesive Tape
510(k) Number K924976
Device Name ALLKARE(TM) ADHESIVE REMOVER WIPE
Applicant
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Applicant Contact STEVEN R PELTIER
Correspondent
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Correspondent Contact STEVEN R PELTIER
Regulation Number878.4730
Classification Product Code
KOX  
Date Received10/01/1992
Decision Date 04/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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