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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 K151918
Device Name Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist
Applicant
Bausch & Lomb Incorporated
1400 N. Goodman St.
Rodchester,  NY  14609
Applicant Contact Barbara Klube-Falso
Correspondent
Bausch & Lomb Incorporated
1400 N. Goodman St.
Rodchester,  NY  14609
Correspondent Contact Barbara Klube-Falso
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received07/13/2015
Decision Date 02/11/2016
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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