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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 K934198
Device Name OPTIKOS SHAMI, INC. SPECTACLE FRAMES
Applicant
Optikos Shami, Inc.
15375 Barranca Pkwy.
Suite G106
Irvine,  CA  92718
Applicant Contact RAY BILBESSI
Correspondent
Optikos Shami, Inc.
15375 Barranca Pkwy.
Suite G106
Irvine,  CA  92718
Correspondent Contact RAY BILBESSI
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received08/26/1993
Decision Date 10/04/1993
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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