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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lens, contact, (disposable)
510(k) Number K143190
Device Name Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
Applicant
YUNG SHENG OPTICAL CO., LTD.
3F-1, NO. 6, JHONGKE ROAD, DAYA DISTRICT
TAICHUNG CITY,  TW 42881
Applicant Contact WEN-HAN CHEN
Correspondent
YUNG SHENG OPTICAL CO., LTD.
3F-1, NO. 6, JHONGKE ROAD, DAYA DISTRICT
TAICHUNG CITY,  TW 42881
Correspondent Contact WEN-HAN CHEN
Regulation Number886.5925
Classification Product Code
MVN  
Subsequent Product Code
LPL  
Date Received11/05/2014
Decision Date 01/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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