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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 K123994
Device Name DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
Applicant
Ciba Vision Corporation
11460 Johns Creek Pkwy.
Duluth,  GA  30097
Applicant Contact MARTINA HEIM, PH.D., RAC
Correspondent
Ciba Vision Corporation
11460 Johns Creek Pkwy.
Duluth,  GA  30097
Correspondent Contact MARTINA HEIM, PH.D., RAC
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received12/26/2012
Decision Date 02/21/2013
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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