ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER

Powered Laser Surgical Instrument

HGM, INC.

The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Endocoagulator Models 8 And 20 Argon Laser.

Pre-market Notification Details

Device IDK873773
510k NumberK873773
Device Name:ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER
ClassificationPowered Laser Surgical Instrument
Applicant HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
ContactDennis Reigle
CorrespondentDennis Reigle
HGM, 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 Received1987-09-16
Decision Date1987-10-13

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