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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 K953808
Device Name CHENG CHEN HSING NON-PRESCRIPTION SUNGLASSES
Applicant
Cheng Chen Hsing Enterp. & Fact. Co. , Ltd.
# 7, Tai-Yi-One St.
Jente Hsiang
Tainan Hsien,  TW
Applicant Contact CHEN-CHUNG CHIU
Correspondent
Cheng Chen Hsing Enterp. & Fact. Co. , Ltd.
# 7, Tai-Yi-One St.
Jente Hsiang
Tainan Hsien,  TW
Correspondent Contact CHEN-CHUNG CHIU
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/07/1995
Decision Date 10/25/1995
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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