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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 K173086
Device Name NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Applicant
Visioneering Technologies, Inc.
10745 Westside Way
Suite 200
Alpharetta,  GA  30009
Applicant Contact Stephen Snowdy
Correspondent
Regsolutions, LLC
174 Watercolor Way
Suite 103-403
Santa Rosa Beach,  FL  32459
Correspondent Contact Penny Northcutt
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received09/29/2017
Decision Date 11/07/2017
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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