UROLAB SPECTRUM

Cystometric Gas (carbon-dioxide) On Hydraulic Device

LIFE-TECH INTL., INC.

The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Urolab Spectrum.

Pre-market Notification Details

Device IDK931179
510k NumberK931179
Device Name:UROLAB SPECTRUM
ClassificationCystometric Gas (carbon-dioxide) On Hydraulic Device
Applicant LIFE-TECH INTL., INC. P.O. BOX 36221 Houston,  TX  77236 -6221
ContactAlfred Coats
CorrespondentAlfred Coats
LIFE-TECH INTL., INC. P.O. BOX 36221 Houston,  TX  77236 -6221
Product CodeFAP  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-09
Decision Date1993-11-18

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