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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 K251162
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 Received04/15/2025
Decision Date 10/08/2025
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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