Cleared Traditional

ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER

K871424 · Hgm, Inc. · Ear, Nose, Throat

Jul 1987

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K871424 is an FDA 510(k) clearance for the ENDOCOAGULATOR MODEL 5, 8 & 20 ARGON LASER, a Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology (Class II — Special Controls, product code LMS), submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 8, 1987, 90 days after receiving the submission on April 9, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4490.

Submission Details

510(k) Number	K871424 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 1987
Decision Date	July 08, 1987
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

Device Classification

Product Code	LMS — Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4490