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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 K050065
Device Name FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
Applicant
CIBA VISION CORPORATION
11440 JOHNS CREEK PARKWAY
DULUTH,  GA  30097
Applicant Contact PENNY NORTHCUTT, RAC
Correspondent
CIBA VISION CORPORATION
11440 JOHNS CREEK PARKWAY
DULUTH,  GA  30097
Correspondent Contact PENNY NORTHCUTT, RAC
Regulation Number886.5925
Classification Product Code
MVN  
Date Received01/12/2005
Decision Date 05/27/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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