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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 K181920
Device Name Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
Applicant
CooperVision, Inc.
5870 Stoneridge Drive
Suite 1
Pleasanton,  CA  94588
Applicant Contact Marie Dutton
Correspondent
CooperVision, Inc.
5870 Stoneridge Drive
Suite 1
Pleasanton,  CA  94588
Correspondent Contact Marie Dutton
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received07/18/2018
Decision Date 12/11/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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