FDA 510(k) Application Details - K191435

Device Classification Name	Stimulator, Peripheral Nerve, Implanted (Pain Relief)   More FDA Info for this Device
510(K) Number	K191435
Device Name	Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Applicant	Nalu Medical, Inc. 2320 Faraday Ave. Suite 100 Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Michele Chin-Purcell 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	05/30/2019
Decision Date	09/06/2019
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