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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, ultrasonic surgical
510(k) Number K200774
Device Name CUSA Clarity Ultrasonic Surgical Aspirator System
Applicant
Integra LifeSciences Corporation
1100 Campus Rd
Princeton,  NJ  08540
Applicant Contact Alexandra Wells
Correspondent
Integra LifeSciences Corporation
1100 Campus Rd
Princeton,  NJ  08540
Correspondent Contact Alexandra Wells
Classification Product Code
LFL  
Subsequent Product Code
LBK  
Date Received03/25/2020
Decision Date 06/23/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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