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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 K102258
Device Name CUSA NXT EXTENDED LENGTH TIP
Applicant
Integra Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact KEVIN J O'CONNELL
Correspondent
Integra Radionics, Inc.
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact KEVIN J O'CONNELL
Classification Product Code
LFL  
Date Received08/10/2010
Decision Date 06/10/2011
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
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