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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
Applicant
NUVASIVE, INCORPORATED
7475 LUSK BOULEVARD
SAN DIEGO,  CA  92121
Applicant Contact Elias Ketchum
Correspondent
NUVASIVE, INCORPORATED
7475 LUSK BOULEVARD
SAN DIEGO,  CA  92121
Correspondent Contact Elias Ketchum
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/19/2011
Decision Date 02/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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