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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 K003586
Device Name FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENSES
Applicant
Ciba-Geigy Corp.
11460 Johns Creek Pkwy.
Duluth,  GA  30136
Applicant Contact STEVEN DOWDLEY
Correspondent
Ciba-Geigy Corp.
11460 Johns Creek Pkwy.
Duluth,  GA  30136
Correspondent Contact STEVEN DOWDLEY
Regulation Number886.5925
Classification Product Code
MVN  
Subsequent Product Code
LPL  
Date Received11/20/2000
Decision Date 02/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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