LABORIE URODYNAMICS PROCESSOR

Cystometric Gas (carbon-dioxide) On Hydraulic Device

R. LABORIE SURGICAL LTD.

The following data is part of a premarket notification filed by R. Laborie Surgical Ltd. with the FDA for Laborie Urodynamics Processor.

Pre-market Notification Details

Device IDK920777
510k NumberK920777
Device Name:LABORIE URODYNAMICS PROCESSOR
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
Applicant R. LABORIE SURGICAL LTD. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
ContactJames R Veale
CorrespondentJames R Veale
R. LABORIE SURGICAL LTD. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
Product CodeFAP  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-20
Decision Date1992-09-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.