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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 K991163
Device Name VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR
Applicant
Vistakon, Johnson & Johnson Vision Products, Inc.
4500 Salisbury Rd., Suite 300
Jacksonville,  FL  32216
Applicant Contact MARTINE D MARTINO
Correspondent
Vistakon, Johnson & Johnson Vision Products, Inc.
4500 Salisbury Rd., Suite 300
Jacksonville,  FL  32216
Correspondent Contact MARTINE D MARTINO
Regulation Number886.5925
Classification Product Code
LPL  
Date Received04/07/1999
Decision Date 06/08/1999
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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