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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 K141674
Device Name CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Applicant
Integra LifeSciences Corporation
311 Enterprise Dr.
Plainsboro,  NJ  08535
Applicant Contact TIMOTHY CONNORS
Correspondent
Integra LifeSciences Corporation
311 Enterprise Dr.
Plainsboro,  NJ  08535
Correspondent Contact TIMOTHY CONNORS
Classification Product Code
LFL  
Date Received06/23/2014
Decision Date 11/06/2014
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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