Cleared Traditional

LASER PHOTOCOAGULATOR

K837306 · Hgm, Inc. · Radiology
Apr 1983
Decision
31d
Days
Risk

About This 510(k) Submission

K837306 is an FDA 510(k) clearance for the LASER PHOTOCOAGULATOR, submitted by Hgm, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 21, 1983, 31 days after receiving the submission on March 21, 1983. This device falls under the Radiology review panel.

Submission Details

510(k) Number K837306 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 1983
Decision Date April 21, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code
Device Class