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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve
510(k) Number K112709
Device Name STIMULATION/DISSECTION INSTRUMENTS
Original Applicant
NUVASIVE, INCORPORATED
7475 lusk boulevard
san diego,  CA  92121
Original Contact elias ketchum
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/19/2011
Decision Date 02/09/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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