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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 K033701
Device Name FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
Applicant
Ciba Vision Corporation
11440 Johns Creek Pkwy.
Duluth,  GA  30097
Applicant Contact ALICIA M PLESNARSKI
Correspondent
Ciba Vision Corporation
11440 Johns Creek Pkwy.
Duluth,  GA  30097
Correspondent Contact ALICIA M PLESNARSKI
Regulation Number886.5925
Classification Product Code
MVN  
Subsequent Product Code
LPL  
Date Received11/25/2003
Decision Date 12/15/2003
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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