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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 K932940
Device Name SUNGLASSES
Applicant
Sun and Young Sunglasses Co., Ltd.
2 Floor # 113, Tzu-Chiang Rd.,
Yungkang Hsiang,Tainan Hsien
Taiwan,The Republic Of Ch,  TW
Applicant Contact MICHAEL HSU
Correspondent
Sun and Young Sunglasses Co., Ltd.
2 Floor # 113, Tzu-Chiang Rd.,
Yungkang Hsiang,Tainan Hsien
Taiwan,The Republic Of Ch,  TW
Correspondent Contact MICHAEL HSU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/16/1993
Decision Date 09/20/1993
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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