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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 K855018
Device Name DURAHESIVE WAFER WITH FLANGE
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 02/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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