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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 K010114
Device Name ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR)
Applicant
Johnson & Johnson Vision Care, Inc.
7500 Centurion Pkwy.
Jacksonville,  FL  32256
Applicant Contact SHARON BRIGGS
Correspondent
Johnson & Johnson Vision Care, Inc.
7500 Centurion Pkwy.
Jacksonville,  FL  32256
Correspondent Contact SHARON BRIGGS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received01/16/2001
Decision Date 04/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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