CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE

Cystometric Gas (carbon-dioxide) On Hydraulic Device

KLI

The following data is part of a premarket notification filed by Kli with the FDA for Co2 Cystoscopy/urethroscopy Console.

Pre-market Notification Details

Device IDK800822
510k NumberK800822
Device Name:CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
Applicant KLI 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFAP  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-14
Decision Date1980-06-17

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