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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 K180299
Device Name ACUVUE OASYS (senofilcon A) with Photochromic Additive
Applicant
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway, Suite 100
jacksonville,  FL  32256
Applicant Contact victoria brennand
Correspondent
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway, Suite 100
jacksonville,  FL  32256
Correspondent Contact victoria brennand
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received02/02/2018
Decision Date 04/10/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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