MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN

Laser, Surgical, Gynecologic

HGM, INC.

The following data is part of a premarket notification filed by Hgm, Inc. with the FDA for Model 8 & 20 Argon Laser For Pelvic Surgery In Gyn.

Pre-market Notification Details

Device IDK862227
510k NumberK862227
Device Name:MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN
ClassificationLaser, Surgical, Gynecologic
Applicant HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
ContactLanducci, M.d.
CorrespondentLanducci, M.d.
HGM, INC. 3959 WEST 1820 SOUTH Salt Lake City,  UT  84104
Product CodeHHR  
CFR Regulation Number884.4550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-11
Decision Date1986-08-19

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