FDA 510(k) Application Details - K100912

Device Classification Name	Electrode, Needle   More FDA Info for this Device
510(K) Number	K100912
Device Name	Electrode, Needle
Applicant	KIRWAN SURGICAL PRODUCTS, INC. 180 ENTERPRISE DR. MARSHFIELD, MA 02050 US Other 510(k) Applications for this Company
Contact	KEVIN P PRARIO Other 510(k) Applications for this Contact
Regulation Number	882.1350   More FDA Info for this Regulation Number
Classification Product Code	GXZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2010
Decision Date	08/19/2010
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