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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 K945036
Device Name BRIGHTEN
Applicant
New Daley Intl. Trading Co.
90-65 55th Ave., 2nd Floor
Elmhurst,  NY  11373
Applicant Contact KIAO M HE
Correspondent
New Daley Intl. Trading Co.
90-65 55th Ave., 2nd Floor
Elmhurst,  NY  11373
Correspondent Contact KIAO M HE
Regulation Number886.5850
Classification Product Code
HQY  
Date Received10/13/1994
Decision Date 11/22/1994
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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