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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 K240493
Device Name CUSA® Clarity Ultrasonic Surgical Aspirator System
Applicant
Integra LifeSciences Corporation
1100 Campus Rd. Princeton
Princeton,  NJ  08540
Applicant Contact Karen Monaghan
Correspondent
Integra LifeSciences Corporation
1100 Campus Rd. Princeton
Princeton,  NJ  08540
Correspondent Contact Karen Monaghan
Classification Product Code
LFL  
Subsequent Product Code
LBK  
Date Received02/20/2024
Decision Date 07/11/2024
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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