MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE

Laser For Gastro-urology Use

LASERMATIC, INC.

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

Pre-market Notification Details

Device IDK871934
510k NumberK871934
Device Name:MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE
ClassificationLaser For Gastro-urology Use
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 CodeLNK  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-05-19
Decision Date1988-03-25

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