FDA 510(k) Application Details - K093591

Device Classification Name	Stimulator, Nerve, Battery-Powered   More FDA Info for this Device
510(K) Number	K093591
Device Name	Stimulator, Nerve, Battery-Powered
Applicant	XAVANT TECHNOLOGY (PTY), LTD. 169 GARSFONTEIN ROAD ASHLEA GARDENS PRETORIA, GAUTENG 0081 ZA Other 510(k) Applications for this Company
Contact	BRIAN ROTHMAN Other 510(k) Applications for this Contact
Regulation Number	868.2775   More FDA Info for this Regulation Number
Classification Product Code	BXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2009
Decision Date	12/03/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review