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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 K180322
Device Name Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
Applicant
Visco Vision, Inc.
# 1, Xingye St., Guishan Dist.,
Taoyuan City,  TW 33341
Applicant Contact Evan Huang
Correspondent
Jens Medical Consulting, Ltd.
6f, # 39, Jixian Rd., Luzhou Dist.
New Taipei City,  TW 247
Correspondent Contact Jennifer Ting
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received02/05/2018
Decision Date 04/20/2018
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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