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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 K113703
Device Name BAUSCH + LOMB NESOFILCON A CONTACT LENS
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 Received12/16/2011
Decision Date 06/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT01365039
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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