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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 K112718
Device Name NUVASIVE NVM5 SYSTEM
Applicant
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO,  CA  92121
Applicant Contact Elias Ketchum
Correspondent
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO,  CA  92121
Correspondent Contact Elias Ketchum
Regulation Number874.1820
Classification Product Code
ETN  
Subsequent Product Codes
GWF   HAW   IKN  
Date Received09/19/2011
Decision Date 03/16/2012
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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