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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 K220070
Device Name MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
Applicant
CooperVision, Inc.
6101 Bollinger Canyon Rd., Suite 500
San Ramon,  CA  94583
Applicant Contact Marie Dutton
Correspondent
CooperVision, Inc.
6101 Bollinger Canyon Rd., Suite 500
San Ramon,  CA  94583
Correspondent Contact Marie Dutton
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received01/10/2022
Decision Date 02/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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