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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 K111741
Device Name INTEGRA(TM) CUSA NXT(TM) BONE TIPS
Applicant
Integra Burlington Ma, Inc. (Formerly Integra Radi
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact KEVIN J O'CONNELL
Correspondent
Integra Burlington Ma, Inc. (Formerly Integra Radi
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact KEVIN J O'CONNELL
Classification Product Code
LFL  
Date Received06/21/2011
Decision Date 08/23/2011
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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