ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER

Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology

HGM, INC.

The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Endocoagulator Model 5, 8 & 20 Argon Laser.

Pre-market Notification Details

Device IDK871424
510k NumberK871424
Device Name:ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER
ClassificationLaser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
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 CodeLMS  
CFR Regulation Number874.4490 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-09
Decision Date1987-07-08

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