FDA 510(k) Application Details - K063753

Device Classification Name	Generator, Lesion, Radiofrequency   More FDA Info for this Device
510(K) Number	K063753
Device Name	Generator, Lesion, Radiofrequency
Applicant	ACI, INC. 555 ZANG STREET SUITE 100 DENVER, CO 80228 US Other 510(k) Applications for this Company
Contact	CLAY ANSELMO 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	12/19/2006
Decision Date	06/20/2007
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	Y
Expedited Review