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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 K962804
Device Name ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER
Applicant
Vistakon, Johnson & Johnson Vision Products, Inc.
P.O. Box 10157
Jacksonville,  FL  32247
Applicant Contact DENISE E MCEACHERN
Correspondent
Vistakon, Johnson & Johnson Vision Products, Inc.
P.O. Box 10157
Jacksonville,  FL  32247
Correspondent Contact DENISE E MCEACHERN
Regulation Number886.5925
Classification Product Code
LPL  
Date Received07/18/1996
Decision Date 10/01/1996
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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