FDA 510(k) Application Details - K180981

Device Classification Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)   More FDA Info for this Device
510(K) Number	K180981
Device Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant	Stimwave Technologies Incorporated 1310 Park Central Boulevard South Pompano Beach, FL 33064 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	04/13/2018
Decision Date	09/19/2018
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