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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, ophthalmic
510(k) Number K850572
Device Name HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K
Applicant
HGM, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact JEROME STENEHJEM
Correspondent
HGM, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact JEROME STENEHJEM
Regulation Number886.4390
Classification Product Code
HQF  
Date Received02/13/1985
Decision Date 04/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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