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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 K161882
Device Name CUSA Clarity Ultrasonic Surgical Aspirator System
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Applicant Contact RESHAM RAMSAY
Correspondent
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Correspondent Contact RESHAM RAMSAY
Classification Product Code
LFL  
Subsequent Product Code
LBK  
Date Received07/11/2016
Decision Date 10/14/2016
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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