SURGICA(TM) H

Powered Laser Surgical Instrument

HGM MEDICAL LASER SYSTEMS, INC.

The following data is part of a premarket notification filed by Hgm Medical Laser Systems, Inc. with the FDA for Surgica(tm) H.

Pre-market Notification Details

Device IDK910898
510k NumberK910898
Device Name:SURGICA(TM) H
ClassificationPowered Laser Surgical Instrument
Applicant HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
ContactDennis Reigle
CorrespondentDennis Reigle
HGM MEDICAL LASER SYSTEMS, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-04
Decision Date1991-05-31

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