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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 K191763
Device Name MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
Applicant
CooperVision, Inc.
5870 Stoneridge Dr., Suite 1
Pleasanton,  CA  94588
Applicant Contact Marie Dutton
Correspondent
CooperVision, Inc.
5870 Stoneridge Dr., Suite 1
Pleasanton,  CA  94588
Correspondent Contact Marie Dutton
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received07/01/2019
Decision Date 03/23/2020
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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