LASERSAT CO2

Powered Laser Surgical Instrument

SATELEC

The following data is part of a premarket notification filed by Satelec with the FDA for Lasersat Co2.

Pre-market Notification Details

Device IDK904067
510k NumberK904067
Device Name:LASERSAT CO2
ClassificationPowered Laser Surgical Instrument
Applicant SATELEC Z.I. DU PHARE, B.P. 216 17, AVENUE GUSTAVE EIFFEL Merignac Cedex,  FR 33708
ContactDupeyron
CorrespondentDupeyron
SATELEC Z.I. DU PHARE, B.P. 216 17, AVENUE GUSTAVE EIFFEL Merignac Cedex,  FR 33708
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-08-31
Decision Date1990-11-07

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