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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Ostomy
510(k) Number K855019
Device Name DURAHESIVE PROTECTIVE BARRIER WIPE
Applicant
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Applicant Contact PETER C KALLOS
Correspondent
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Correspondent Contact PETER C KALLOS
Regulation Number876.5900
Classification Product Code
EXB  
Date Received12/16/1985
Decision Date 04/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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