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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 K133176
Device Name AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS 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  
Date Received10/17/2013
Decision Date 01/29/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT01338402
NCT01398787
NCT01440322
NCT01614678
NCT01635920
NCT01635933
NCT01782482
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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