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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 K141668
FOIA Releasable 510(k) K141668
Device Name CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Applicant
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08535
Applicant Contact JANET C KAY
Correspondent
INTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO,  NJ  08535
Correspondent Contact JANET C KAY
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
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