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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 K931784
Device Name HGM ILLUMINATING IMAGING ENDOCULAR PROBE
Applicant
Hgm, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact JOSEPH G LAMBERT
Correspondent
Hgm, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact JOSEPH G LAMBERT
Regulation Number886.4390
Classification Product Code
HQF  
Date Received04/09/1993
Decision Date 03/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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