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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact, (Disposable)
510(k) Number K112192
Device Name NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
Applicant
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact TRICIA GARRETT
Correspondent
Bausch & Lomb, Inc.
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact TRICIA GARRETT
Regulation Number886.5925
Classification Product Code
MVN  
Date Received07/29/2011
Decision Date 10/25/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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