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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 K791265
Device Name CONPHAR URINARY DRAINAGE BAG-2000ML
Original Applicant
CONPHAR, INC.
Regulation Number876.5250
Classification Product Code
KNX  
Date Received07/06/1979
Decision Date 09/07/1979
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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