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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 K081459
FOIA Releasable 510(k) K081459
Device Name CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
Applicant
INTEGRA RADIONICS, INC.
22 TERRY AVENUE
BURLINGTON,  MA  01803
Applicant Contact KEVIN J O'CONNELL
Correspondent
INTEGRA RADIONICS, INC.
22 TERRY AVENUE
BURLINGTON,  MA  01803
Correspondent Contact KEVIN J O'CONNELL
Classification Product Code
LFL  
Date Received05/23/2008
Decision Date 08/13/2008
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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