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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 K922776
Device Name FST COUNCIL TIP FOLEY CATHETER
Applicant
FIBEROPTIC SENSOR TECHNLOGIES, INC.
501 AVIS DR.
ANN ARBOR,  MI  48108
Applicant Contact MICHAEL D COLLIVER
Correspondent
FIBEROPTIC SENSOR TECHNLOGIES, INC.
501 AVIS DR.
ANN ARBOR,  MI  48108
Correspondent Contact MICHAEL D COLLIVER
Regulation Number876.1620
Classification Product Code
FEN  
Date Received06/09/1992
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
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