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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 K862251
Device Name MODIFIED BIO-FLOW MODEL 200 URINE FLOW DEVICE
Original Applicant
BIO-FLOW, INC.
3303 harbor blvd.
suite h6
costa mesa,  CA  92626
Original Contact thomas e hyans
Regulation Number876.5250
Classification Product Code
KNX  
Date Received06/12/1986
Decision Date 09/04/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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