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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 K933453
Device Name MULTIPLE
Applicant
Fortuna Optical Factory , Ltd.
6128 NW 11th St.
Sunrise,  FL  33313
Applicant Contact LEO SANDERS
Correspondent
Fortuna Optical Factory , Ltd.
6128 NW 11th St.
Sunrise,  FL  33313
Correspondent Contact LEO SANDERS
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received07/13/1993
Decision Date 10/13/1993
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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