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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 K950908
Device Name FST CATH-UD, CATHETER
Applicant
FIBEROPTIC SENSOR TECHNLOGIES, INC.
501 AVIS DR.
ANN ARBOR,  MI  48108
Applicant Contact GARY C SIMPSON
Correspondent
FIBEROPTIC SENSOR TECHNLOGIES, INC.
501 AVIS DR.
ANN ARBOR,  MI  48108
Correspondent Contact GARY C SIMPSON
Regulation Number876.1620
Classification Product Code
FEN  
Date Received02/16/1995
Decision Date 04/07/1995
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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