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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 K032340
Device Name VISTAKON (GALYFILCON A) SOFT CONTACT LENS
Applicant
JOHNSON & JOHNSON VISION CARE, INC.
7500 CENTURION PARKWAY,
SUITE 100
JACKSONVILLE,  FL  32256
Applicant Contact JACQUELINE ZIMOVAN
Correspondent
JOHNSON & JOHNSON VISION CARE, INC.
7500 CENTURION PARKWAY,
SUITE 100
JACKSONVILLE,  FL  32256
Correspondent Contact JACQUELINE ZIMOVAN
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received07/29/2003
Decision Date 10/16/2003
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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