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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 K182809
Device Name CUSA Clarity Ultrasonic Surgical Aspirator System
Applicant
Integra LifeSciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact MaryBeth Carson
Correspondent
Integra LifeSciences Corporation
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact MaryBeth Carson
Classification Product Code
LFL  
Subsequent Product Code
LBK  
Date Received10/03/2018
Decision Date 12/07/2018
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
Recalls CDRH Recalls
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