Cleared Traditional

LASER PHOTOCOAGULATOR

K837422 · Hgm, Inc. · Radiology

Jun 1983

Decision

49d

Days

—

Risk

About This 510(k) Submission

K837422 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 June 10, 1983, 49 days after receiving the submission on April 22, 1983. This device falls under the Radiology review panel.

Submission Details

510(k) Number	K837422 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 1983
Decision Date	June 10, 1983
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—