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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 K130931
Device Name EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS
Applicant
Jiangsu Horien Contact Lens Co., Ltd.
2904 N. Boldt Dr.
Flagstaff,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
Jiangsu Horien Contact Lens Co., Ltd.
2904 N. Boldt Dr.
Flagstaff,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number886.5925
Classification Product Code
LPL  
Date Received04/04/2013
Decision Date 08/30/2013
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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