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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 K962604
Device Name PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
Applicant
Convatec, A Division of E.R. Squibb & Sons
100 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact GEORGE J PRENDERGAST
Correspondent
Convatec, A Division of E.R. Squibb & Sons
100 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact GEORGE J PRENDERGAST
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received07/02/1996
Decision Date 07/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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