Cleared Traditional

ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER

K870773 · Hgm, Inc. · Neurology
Jul 1987
Decision
134d
Days
Class 3
Risk

About This 510(k) Submission

K870773 is an FDA 510(k) clearance for the ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER, a Laser, Neurosurgical, Argon (Class III — Premarket Approval, product code LLF), submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 10, 1987, 134 days after receiving the submission on February 26, 1987. This device falls under the Neurology review panel.

Submission Details

510(k) Number K870773 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1987
Decision Date July 10, 1987
Days to Decision 134 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code LLF — Laser, Neurosurgical, Argon
Device Class Class III — Premarket Approval