HGM, INC. LASERCATH (STERILE)

Laser For Gastro-urology Use

HGM, INC.

The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Hgm, Inc. Lasercath (sterile).

Pre-market Notification Details

Device IDK860357
510k NumberK860357
Device Name:HGM, INC. LASERCATH (STERILE)
ClassificationLaser For Gastro-urology Use
Applicant HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
ContactGreg Mcarthur
CorrespondentGreg Mcarthur
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 Received1986-01-30
Decision Date1986-04-07

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