FST CATH UD-DUAL DUAL PRESSURE 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-dual Dual Pressure Catheter.

Pre-market Notification Details

Device IDK926088
510k NumberK926088
Device Name:FST CATH UD-DUAL DUAL PRESSURE CATHETER
ClassificationDevice, Cystometric, Hydraulic
Applicant FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor,  MI  48108
ContactDouglas G Tomasko
CorrespondentDouglas G Tomasko
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 Received1992-12-02
Decision Date1993-06-18

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