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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 K182734
Device Name Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
Applicant
Unicon Optical Co., Ltd.
No 16, Gongye E. 9th Rd.
Hsinchu Science Park, Baoshan Township
Hsinchu County,  TW 30075
Applicant Contact HSIAO-WEI SHEN
Correspondent
Unicon Optical Co., Ltd.
No 16, Gongye E. 9th Rd.
Hsinchu Science Park, Baoshan Township
Hsinchu County,  TW 30075
Correspondent Contact HSIAO-WEI SHEN
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received09/28/2018
Decision Date 05/16/2019
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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