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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 K200528
Device Name Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism
Applicant
Bausch + Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14609
Applicant Contact Barbara Klube-Falso
Correspondent
Bausch + Lomb, Incorporated
1400 N. Goodman St.
Rochester,  NY  14609
Correspondent Contact Barbara Klube-Falso
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received03/02/2020
Decision Date 06/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT04158466
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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