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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 K061157
Device Name SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
Applicant
Bausch & Lomb
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact DEBRA KETCHUM
Correspondent
Bausch & Lomb
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact DEBRA KETCHUM
Regulation Number886.5925
Classification Product Code
MVN  
Date Received04/26/2006
Decision Date 06/22/2006
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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