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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K962310
Device Name NON-GENERIC
Applicant
CLASSIC ELEGANCE INTL., INC.
20639 LYCOMING ST., #B-9
DIAMOND BAR,  CA  91789
Applicant Contact FOOK LOY SOTHAM
Correspondent
CLASSIC ELEGANCE INTL., INC.
20639 LYCOMING ST., #B-9
DIAMOND BAR,  CA  91789
Correspondent Contact FOOK LOY SOTHAM
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/17/1996
Decision Date 07/03/1996
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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