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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 K150293
Device Name EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)
Applicant
I-See Vision Technology, Inc.
1f, # 45, Ln. 2, Sec. 2, Kuang-Fu Rd.
Hsinchu,  TW 30071
Applicant Contact ISAAC HUANG
Correspondent
Eyereg Consulting, Inc.
474 NE 61st Pl.
Hillsboro,  OR  97124
Correspondent Contact BRET ANDRE
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received02/06/2015
Decision Date 04/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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