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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K090298
Device Name NUVASIVE NEURO VISION SYSTEM
Applicant
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO,  CA  92121
Applicant Contact HAN FAN
Correspondent
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO,  CA  92121
Correspondent Contact HAN FAN
Regulation Number882.1870
Classification Product Code
GWF  
Date Received02/06/2009
Decision Date 06/08/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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