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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 K852464
Device Name HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.
Applicant
Hcg, Inc.
1828 S. 3850 W.
Salt Lake City,  UT  84104
Applicant Contact JEROME STENEHJEM
Correspondent
Hcg, Inc.
1828 S. 3850 W.
Salt Lake City,  UT  84104
Correspondent Contact JEROME STENEHJEM
Regulation Number886.4390
Classification Product Code
HQF  
Date Received06/10/1985
Decision Date 07/25/1985
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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