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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 K033919
Device Name CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS
Applicant
Ciba Vision Corporation
11440 Johns Creek Pkwy.
Duluth,  GA  30097 -1556
Applicant Contact ALICIA M PLESNARSKI
Correspondent
Ciba Vision Corporation
11440 Johns Creek Pkwy.
Duluth,  GA  30097 -1556
Correspondent Contact ALICIA M PLESNARSKI
Regulation Number886.5925
Classification Product Code
LPL  
Date Received12/18/2003
Decision Date 03/12/2004
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
Recalls CDRH Recalls
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