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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
510(k) Number K851483
Device Name UROBEI STRESS INCONTINENCE MONITOR
Applicant
Browne Medical, Inc.
1035 Cindy Ln.
Carpinteria,  CA 
Applicant Contact MAUREEN WRIGHT
Correspondent
Browne Medical, Inc.
1035 Cindy Ln.
Carpinteria,  CA 
Correspondent Contact MAUREEN WRIGHT
Regulation Number876.1620
Classification Product Code
FAP  
Date Received04/15/1985
Decision Date 08/07/1985
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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