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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 K113570
Device Name INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP
Original Applicant
INTEGRA BURLINGTON MA, INC.
22 terry ave.
burlington,  MA  01803
Original Contact lindsay mignone
Classification Product Code
LFL  
Date Received12/02/2011
Decision Date 02/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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