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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 K904699
Device Name COMPAC(TM) DIODE LASERS
Applicant
HGM MEDICAL LASER SYSTEMS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact DENNIS REIGLE
Correspondent
HGM MEDICAL LASER SYSTEMS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact DENNIS REIGLE
Regulation Number886.4390
Classification Product Code
HQF  
Date Received10/16/1990
Decision Date 04/25/1991
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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