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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Frame, Spectacle
510(k) Number K934797
Device Name FINE OPTICS
Applicant
Fine Optics, Inc.
1232 S. Hooper Ave.
Los Angeles,  CA  90021
Applicant Contact DAVID FINE
Correspondent
Fine Optics, Inc.
1232 S. Hooper Ave.
Los Angeles,  CA  90021
Correspondent Contact DAVID FINE
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received10/06/1993
Decision Date 12/08/1993
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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