FDA 510(k) Application Details - K141399

Device Classification Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)   More FDA Info for this Device
510(K) Number	K141399
Device Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant	STIMWAVE TECHNOLOGIES INCORPORATED 420 Lincoln Rd Suite 365 Miami Beach, FL 33139 US Other 510(k) Applications for this Company
Contact	Elizabeth Greene 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	05/28/2014
Decision Date	10/10/2014
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