FDA 510(k) Application Details - K062758

Device Classification Name	Generator, Lesion, Radiofrequency   More FDA Info for this Device
510(K) Number	K062758
Device Name	Generator, Lesion, Radiofrequency
Applicant	DIROS TECHNOLOGY, INC. 232 HOOD ROAD MARKHAM, ONTARIO L3R 3K8 CA Other 510(k) Applications for this Company
Contact	GEORGE DARMOS Other 510(k) Applications for this Contact
Regulation Number	882.4400   More FDA Info for this Regulation Number
Classification Product Code	GXD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/15/2006
Decision Date	09/27/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review