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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 K152942
Device Name NuVasiveNVM5 System
Applicant
Nu Vasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Applicant Contact Olga Lewis
Correspondent
Nu Vasive, Incorporated
7475 Lusk Blvd.
San Diego,  CA  92121
Correspondent Contact Olga Lewis
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Codes
ETN   GWF   HAW   IKN   OLO  
Date Received10/05/2015
Decision Date 01/13/2016
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
Predetermined Change
Control Plan Authorized		 No
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