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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, cystometric, hydraulic
510(k) Number K930171
Device Name FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR
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
FEN  
Date Received01/13/1993
Decision Date 11/04/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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