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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K143052
Device Name Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens
Applicant
Yung Sheng Optical Co., Ltd.
3f-1, # 6, Jhongke Rd., Daya District
Taichung City,  TW 42881
Applicant Contact Wen-Han Chen
Correspondent
Yung Sheng Optical Co., Ltd.
3f-1, # 6, Jhongke Rd., Daya District
Taichung City,  TW 42881
Correspondent Contact Wen-Han Chen
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received10/23/2014
Decision Date 12/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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