510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K837306Substantially Equivalent

Laser Photocoagulator

Hgm, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K837306 is the FDA 510(k) clearance record for LASER PHOTOCOAGULATOR, cleared for Hgm, Inc. on . FDA records list 21 510(k) clearances for Hgm, Inc., from to . As of , FDA records show no recalls naming K837306.

Clearance record

Decision date
Received
(31 days to decision)
Review panel
Unknown
Applicant
Hgm, Inc. 3959 W. 1820 S., Salt Lake City UT
Third party review
No