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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 K062614
Device Name VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)
Applicant
JOHNSON & JOHNSON VISION CARE, INC.
7500 CENTURION PKWY.
SUITE 100
jacksonville,  FL  32256
Applicant Contact susan morris
Correspondent
JOHNSON & JOHNSON VISION CARE, INC.
7500 CENTURION PKWY.
SUITE 100
jacksonville,  FL  32256
Correspondent Contact susan morris
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/05/2006
Decision Date 11/01/2006
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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