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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 K922476
Device Name URO-PRO 2000
Applicant
Fiberoptic Sensor Technlogies, Inc.
501 Avis Dr.
Ann Arbor,  MI  48108
Applicant Contact DOUGLAS G TOMASKO
Correspondent
Fiberoptic Sensor Technlogies, Inc.
501 Avis Dr.
Ann Arbor,  MI  48108
Correspondent Contact DOUGLAS G TOMASKO
Regulation Number876.1620
Classification Product Code
FAP  
Subsequent Product Code
EXY  
Date Received05/26/1992
Decision Date 07/20/1993
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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