FDA 510(k) Application Details - K094054

Device Classification Name	Stimulator, Electrical, Evoked Response   More FDA Info for this Device
510(K) Number	K094054
Device Name	Stimulator, Electrical, Evoked Response
Applicant	NUVASIVE, INC. 4545 TOWNE CENTRE COURT SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Sheila Bruschi Other 510(k) Applications for this Contact
Regulation Number	882.1870   More FDA Info for this Regulation Number
Classification Product Code	GWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/31/2009
Decision Date	05/14/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review