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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 K152657
Device Name SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
Applicant
Smart Performer Corp. , Ltd.
#13-1, Wuquan 1st Rd., Xinzhuang Dist.
New Taipei City,  TW 242
Applicant Contact Jeffersion Shen
Correspondent
Smart Performer Corp. , Ltd.
#13-1, Wuquan 1st Rd., Xinzhuang Dist.
New Taipei City,  TW 242
Correspondent Contact Jeffersion Shen
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/16/2015
Decision Date 05/17/2016
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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