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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 K943501
Device Name SUNGLASSES AND SPORT SUNGLASSES
Applicant
Sino-World Champion Co., Ltd.
# 17, Ln. 99, Yu-Feng St.
Tainan,  TW
Applicant Contact CHUN-CHENG WANG
Correspondent
Sino-World Champion Co., Ltd.
# 17, Ln. 99, Yu-Feng St.
Tainan,  TW
Correspondent Contact CHUN-CHENG WANG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/20/1994
Decision Date 08/16/1994
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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