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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 K932135
Device Name OTT SUNGLASSES
Applicant
Sunnex Fashion Corp.
134 Ta Yung Rd.
Yung Kang Hsiang,Tainan Hsien
Tawain, R.O.C.,  CN
Applicant Contact JOHNSON
Correspondent
Sunnex Fashion Corp.
134 Ta Yung Rd.
Yung Kang Hsiang,Tainan Hsien
Tawain, R.O.C.,  CN
Correspondent Contact JOHNSON
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/03/1993
Decision Date 08/06/1993
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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