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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K132694
Device Name NUVASIVE NVM5 SYSTEM
Applicant
NUVASIVE, INCORPORATED
7475 LUSK BOULEVARD
SAN DIEGO,  CA  92121
Applicant Contact Sheila Bruschi
Correspondent
NUVASIVE, INCORPORATED
7475 LUSK BOULEVARD
SAN DIEGO,  CA  92121
Correspondent Contact Sheila Bruschi
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Codes
ETN   GWF   HAW   IKN   OLO  
Date Received08/29/2013
Decision Date 05/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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