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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 K942011
Device Name SUNGLASSES
Applicant
Shanghai Gopher Arts & Crafts Co., Ltd.
53-01 11th St.
Long Island City,  NY  11101
Applicant Contact ELINA YAP
Correspondent
Shanghai Gopher Arts & Crafts Co., Ltd.
53-01 11th St.
Long Island City,  NY  11101
Correspondent Contact ELINA YAP
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/26/1994
Decision Date 10/03/1994
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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