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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transilluminator, ac-powered
510(k) Number K931072
Device Name HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE
Applicant
HGM, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact JOSEPH G LAMBERT
Correspondent
HGM, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact JOSEPH G LAMBERT
Regulation Number886.1945
Classification Product Code
HJM  
Date Received03/02/1993
Decision Date 11/10/1994
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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