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 IDK905641
510k NumberK905641
Device Name:FST CATH-UD CATHETER
ClassificationDevice, Cystometric, Hydraulic
Applicant FIBEROPTIC SENSOR TECHNLOGIES, INC. 501 AVIS DR. Ann Arbor,  MI  48108
ContactDouglas Tomasko
CorrespondentDouglas 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 Received1990-12-18
Decision Date1991-02-19

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