MODEL 5050 SURGILASER FOR PULMONARY USE

Laser, Neodymium:yag, Pulmonary Surgery

LASERMATIC, INC.

The following data is part of a premarket notification filed by Lasermatic, Inc. with the FDA for Model 5050 Surgilaser For Pulmonary Use.

Pre-market Notification Details

Device IDK871876
510k NumberK871876
Device Name:MODEL 5050 SURGILASER FOR PULMONARY USE
ClassificationLaser, Neodymium:yag, Pulmonary Surgery
Applicant LASERMATIC, INC. P.O. BOX 7848 Dallas,  TX  75209
ContactDonald F Hults
CorrespondentDonald F Hults
LASERMATIC, INC. P.O. BOX 7848 Dallas,  TX  75209
Product CodeLLO  
CFR Regulation Number874.4500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-14
Decision Date1988-01-22

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