FDA 510(k) Application Details - K191466

Device Classification Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)   More FDA Info for this Device
510(K) Number	K191466
Device Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant	Stimwave Technologies Inc. 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	06/03/2019
Decision Date	11/07/2019
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