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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 K851266
Device Name QRI-FLOW URINE FLOW MEASURING DEVICE
Applicant
Bio-Flow, Inc.
3303 Harbor Blvd.
Suite H6
Costa Mesa,  CA  92626
Applicant Contact JOSEPH ROVAN
Correspondent
Bio-Flow, Inc.
3303 Harbor Blvd.
Suite H6
Costa Mesa,  CA  92626
Correspondent Contact JOSEPH ROVAN
Regulation Number876.5250
Classification Product Code
KNX  
Date Received03/29/1985
Decision Date 06/27/1985
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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