LABORIE URODYNAMICS PROCESSOR

Cystometric Gas (carbon-dioxide) On Hydraulic Device

TRIDAK DIVISION OF INDICON, INC.

The following data is part of a premarket notification filed by Tridak Division Of Indicon, Inc. with the FDA for Laborie Urodynamics Processor.

Pre-market Notification Details

Device IDK852856
510k NumberK852856
Device Name:LABORIE URODYNAMICS PROCESSOR
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
Applicant TRIDAK DIVISION OF INDICON, INC. ONE BLUE HILL PLAZA SUITE 815 Pearl River,  NY  10965
ContactCorinne M Ambrosino
CorrespondentCorinne M Ambrosino
TRIDAK DIVISION OF INDICON, INC. ONE BLUE HILL PLAZA SUITE 815 Pearl River,  NY  10965
Product CodeFAP  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-05
Decision Date1985-10-17

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