ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.

Laser For Gastro-urology Use

HGM, INC.

The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Endocoagulator(tm) Model 20 Argon Laser For Urolo..

Pre-market Notification Details

Device IDK872630
510k NumberK872630
Device Name:ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.
ClassificationLaser For Gastro-urology Use
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 CodeLNK  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-06
Decision Date1987-08-25

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