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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 K951504
Device Name SUNNEX FASHION CORP. NON-PRESCRIPTION SUNGLASSES
Applicant
Sunnex Fashion Corp.
134 Ta Yung Rd.
Yung Kang Hsiang,Tainan Hsien
Tawain, R.O.C.,  CN
Applicant Contact JEOU SHENG, LIN
Correspondent
Sunnex Fashion Corp.
134 Ta Yung Rd.
Yung Kang Hsiang,Tainan Hsien
Tawain, R.O.C.,  CN
Correspondent Contact JEOU SHENG, LIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received04/03/1995
Decision Date 04/28/1995
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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