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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 K083216
Device Name CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES
Applicant
Ciba Vision Corporation
11460 Johns Creek Pkwy.
Duluth,  GA  30097
Applicant Contact MARTINA HEIM
Correspondent
Ciba Vision Corporation
11460 Johns Creek Pkwy.
Duluth,  GA  30097
Correspondent Contact MARTINA HEIM
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received10/31/2008
Decision Date 04/14/2009
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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