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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Incontinence, Urosheath Type, Sterile
510(k) Number K942941
Device Name CONQUEST MALE CONTINENCE SYSTEM
Applicant
Convatec, A Bristol-Myers Squibb Co.
P.O. Box Cn 5254
Princeton,  NJ  08543
Applicant Contact MARILYN DREYLING
Correspondent
Convatec, A Bristol-Myers Squibb Co.
P.O. Box Cn 5254
Princeton,  NJ  08543
Correspondent Contact MARILYN DREYLING
Regulation Number876.5250
Classification Product Code
EXJ  
Subsequent Product Code
FAQ  
Date Received06/22/1994
Decision Date 03/17/1995
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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