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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 K935558
Device Name SPECTACLE FRAME/EYEGLASS FRAME
Applicant
Modern Optical , Ltd.
770 Creel Dr.
Wood Dale,  IL  60191
Applicant Contact SANDRA R TURAY
Correspondent
Modern Optical , Ltd.
770 Creel Dr.
Wood Dale,  IL  60191
Correspondent Contact SANDRA R TURAY
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received11/17/1993
Decision Date 01/25/1994
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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