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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bag, urine collection, leg, for external use, sterile
510(k) Number K951945
Device Name PROSYS LEG BAG
Applicant
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
P.O. BOX 4000
PRINCETON,  NJ  08540
Applicant Contact MARILYN DREYLING
Correspondent
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
P.O. BOX 4000
PRINCETON,  NJ  08540
Correspondent Contact MARILYN DREYLING
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received04/26/1995
Decision Date 05/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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