FDA 510(k) Application Details - K190047

Device Classification Name	Stimulator, Peripheral Nerve, Implanted (Pain Relief)   More FDA Info for this Device
510(K) Number	K190047
Device Name	Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Applicant	Bioness Inc. 25103 Rye Canyon Loop Valencia, CA 91355 US Other 510(k) Applications for this Company
Contact	Sageev George Other 510(k) Applications for this Contact
Regulation Number	882.5870   More FDA Info for this Regulation Number
Classification Product Code	GZF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/09/2019
Decision Date	10/31/2019
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