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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 K141670
Device Name ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
Applicant
Johnson & Johnson Vision Care, Inc.
7500 Centurion Pkwy., Suite 100
Jacksonville,  FL  32256
Applicant Contact SCOTT DURLAND
Correspondent
Johnson & Johnson Vision Care, Inc.
7500 Centurion Pkwy., Suite 100
Jacksonville,  FL  32256
Correspondent Contact SCOTT DURLAND
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received06/23/2014
Decision Date 09/18/2014
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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