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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 K013973
Device Name ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC
Applicant
Vistakon
7500 Centurion Pkwy., Suite 100
Jacksonville,  FL  32256
Applicant Contact JAMES W PARZIALE
Correspondent
Vistakon
7500 Centurion Pkwy., Suite 100
Jacksonville,  FL  32256
Correspondent Contact JAMES W PARZIALE
Regulation Number886.5925
Classification Product Code
LPL  
Date Received12/03/2001
Decision Date 02/26/2002
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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