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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
510(k) Number K811925
Device Name UROFLOWMETER
Applicant
C.R. Bard, Inc.
110 Marshall Dr.
Warrendale,  PA  15086
Correspondent
C.R. Bard, Inc.
110 Marshall Dr.
Warrendale,  PA  15086
Regulation Number876.1800
Classification Product Code
FFG  
Date Received07/02/1981
Decision Date 09/08/1981
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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