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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Collector, Urine, (And Accessories) For Indwelling Catheter
510(k) Number K895168
Device Name URO-BAGGIE
Applicant
Cwt Workshop
Va Medical Center
Tuscaloosa,  AL  35404
Applicant Contact KEVIN LIND
Correspondent
Cwt Workshop
Va Medical Center
Tuscaloosa,  AL  35404
Correspondent Contact KEVIN LIND
Regulation Number876.5250
Classification Product Code
KNX  
Date Received08/22/1989
Decision Date 03/22/1990
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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