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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 K920991
Device Name IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION
Applicant
BROWNE MEDICAL SYSTEMS, INC.
8990 SPRINGBROOK DRIVE,
SUITE 120
MINNEAPOLIS,  MN  55433
Applicant Contact AL SHERWOOD
Correspondent
BROWNE MEDICAL SYSTEMS, INC.
8990 SPRINGBROOK DRIVE,
SUITE 120
MINNEAPOLIS,  MN  55433
Correspondent Contact AL SHERWOOD
Regulation Number876.1620
Classification Product Code
FAP  
Date Received02/14/1992
Decision Date 04/10/1992
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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