FDA 510(k) Application Details - K113805

Device Classification Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)   More FDA Info for this Device
510(K) Number	K113805
Device Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant	ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 MINNETONKA, MN 55343 US Other 510(k) Applications for this Company
Contact	RACHEL KENNEDY Other 510(k) Applications for this Contact
Regulation Number	882.5880   More FDA Info for this Regulation Number
Classification Product Code	GZB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2011
Decision Date	02/23/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review