FST CATH-UD, CATHETER

Device, Cystometric, Hydraulic

FIBEROPTIC SENSOR TECHNLOGIES, INC.

The following data is part of a premarket notification filed by Fiberoptic Sensor Technlogies, Inc. with the FDA for Fst Cath-ud, Catheter.

Pre-market Notification Details

Device IDK950908
510k NumberK950908
Device Name:FST CATH-UD, CATHETER
ClassificationDevice, Cystometric, Hydraulic
Applicant FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor,  MI  48108
ContactGary C Simpson
CorrespondentGary C Simpson
FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor,  MI  48108
Product CodeFEN  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-16
Decision Date1995-04-07

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