FDA 510(k) Application Details - K081742

Device Classification Name	Stimulator, Nerve   More FDA Info for this Device
510(K) Number	K081742
Device Name	Stimulator, Nerve
Applicant	BAXANO, INC. 2660 MARINE WAY, SUITE B MOUNTAIN VIEW, CA 94043 US Other 510(k) Applications for this Company
Contact	TRENA DEPEL 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	06/19/2008
Decision Date	09/17/2008
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