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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 K994318
Device Name VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER
Applicant
Vistakon, Johnson & Johnson Vision Products, Inc.
7500 Centurion Pkwy.
Jacksonville,  FL  32256
Applicant Contact SHARON BRIGGS
Correspondent
Vistakon, Johnson & Johnson Vision Products, Inc.
7500 Centurion Pkwy.
Jacksonville,  FL  32256
Correspondent Contact SHARON BRIGGS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received12/22/1999
Decision Date 02/23/2000
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
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