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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 K953767
Device Name PROSYS BEDSIDE DRAINAGE BAG
Applicant
Convatec, A Division of E.R. Squibb & Sons
200 Headquarters Park Dr.
Skillman,  NJ  08558
Applicant Contact SUSIE AMBERGER
Correspondent
Convatec, A Division of E.R. Squibb & Sons
200 Headquarters Park Dr.
Skillman,  NJ  08558
Correspondent Contact SUSIE AMBERGER
Regulation Number876.5250
Classification Product Code
FAQ  
Date Received08/11/1995
Decision Date 12/20/1995
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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