MODEL PC 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 Model Pc Argon Laser.

Pre-market Notification Details

Device IDK880908
510k NumberK880908
Device Name:MODEL PC ARGON LASER
ClassificationPowered Laser Surgical Instrument
Applicant HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
ContactBill Papworth
CorrespondentBill Papworth
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 Received1988-03-03
Decision Date1988-05-03

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