FDA 510(k) Application Details - K170902

Device Classification Name	Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief   More FDA Info for this Device
510(K) Number	K170902
Device Name	Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief
Applicant	SPR Therapeutics, LLC 22901 Millcreek Blvd., Suite 110 Cleveland, OH 44122 US Other 510(k) Applications for this Company
Contact	Kathryn Stager Other 510(k) Applications for this Contact
Regulation Number	882.5890   More FDA Info for this Regulation Number
Classification Product Code	NHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2017
Decision Date	06/26/2017
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