FDA 510(k) Application Details - K111671

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K111671
Device Name	Stimulator, Nerve
Applicant	SEASPINE, INC. 2302 LA MIRADA DR. VISTA, CA 92081-7862 US Other 510(k) Applications for this Company
Contact	DAN MILLER Other 510(k) Applications for this Contact
Regulation Number	874.1820   More FDA Info for this Regulation Number
Classification Product Code	ETN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2011
Decision Date	12/28/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review