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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 K904345
Device Name FASHION FRAMES
Applicant
Sunland Optical Co.
P.O. Box 10018
El Paso,  TX  79991
Applicant Contact JOHANNA JOHNSTON
Correspondent
Sunland Optical Co.
P.O. Box 10018
El Paso,  TX  79991
Correspondent Contact JOHANNA JOHNSTON
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received09/24/1990
Decision Date 10/11/1990
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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