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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 K936033
Device Name SUNGLASSES
Applicant
Tung Fang Mei Shieh Co., Ltd.
Sunny Sunglasses
260 S. Los Angeles St.
Los Angeles,  CA  90012
Applicant Contact ANTHONY SU
Correspondent
Tung Fang Mei Shieh Co., Ltd.
Sunny Sunglasses
260 S. Los Angeles St.
Los Angeles,  CA  90012
Correspondent Contact ANTHONY SU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/17/1993
Decision Date 02/22/1994
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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