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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 K935700
Device Name JIN CHANG SUNGLASSES
Applicant
Jin Chang Enterprise Co., Ltd.
166, Chung Lun, Anting Hsiang
Tainan Hsien,  TW 745
Applicant Contact DAVID WANG
Correspondent
Jin Chang Enterprise Co., Ltd.
166, Chung Lun, Anting Hsiang
Tainan Hsien,  TW 745
Correspondent Contact DAVID WANG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/30/1993
Decision Date 04/06/1994
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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