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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 K072343
FOIA Releasable 510(k) K072343
Device Name NEUROVISION JJB SYSTEM
Applicant
NUVASIVE, INC.
4545 TOWNE CENTRE COURT
SAN DIEGO,  CA  92121
Applicant Contact LAETITIA COUSIN
Correspondent
NUVASIVE, INC.
4545 TOWNE CENTRE COURT
SAN DIEGO,  CA  92121
Correspondent Contact LAETITIA COUSIN
Regulation Number882.1870
Classification Product Code
GWF  
Date Received08/21/2007
Decision Date 10/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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