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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 K073485
Device Name VISTAKON (NARAFILCON) A SOFT CONTACT LENS
Applicant
JOHNSON & JOHNSON VISION CARE, INC.
7500 CENTURION PKWY.
SUITE 100
JACKSONVILLE,  FL  32256
Applicant Contact ROSALIND B WILLIAMS
Correspondent
JOHNSON & JOHNSON VISION CARE, INC.
7500 CENTURION PKWY.
SUITE 100
JACKSONVILLE,  FL  32256
Correspondent Contact ROSALIND B WILLIAMS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received12/12/2007
Decision Date 03/03/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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