MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE

Powered Laser Surgical Instrument

LASER ENGINEERING, INC.

The following data is part of a premarket notification filed by Laser Engineering, Inc. with the FDA for Model Md-45 Co2 Laser For Neurosurgery Use.

Pre-market Notification Details

Device IDK881584
510k NumberK881584
Device Name:MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE
ClassificationPowered Laser Surgical Instrument
Applicant LASER ENGINEERING, INC. 113 CEDAR ST. Milford,  MA  01757
ContactRobert I Rudko
CorrespondentRobert I Rudko
LASER ENGINEERING, INC. 113 CEDAR ST. Milford,  MA  01757
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-11
Decision Date1988-06-03

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