MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT

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-25 Co2 Laser For Ear, Nose & Throat.

Pre-market Notification Details

Device IDK881583
510k NumberK881583
Device Name:MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT
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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