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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 K143632
Device Name Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens
Applicant
Bausch & Lomb Incorporated
1400 N. Goodman St.
Rodchester,  NY  14609
Applicant Contact Jessica Burger
Correspondent
Bausch & Lomb Incorporated
1400 N. Goodman St.
Rodchester,  NY  14609
Correspondent Contact Jessica Burger
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received12/22/2014
Decision Date 02/13/2015
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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