FDA 510(k) Application Details - K052878

Device Classification Name	Generator, Lesion, Radiofrequency   More FDA Info for this Device
510(K) Number	K052878
Device Name	Generator, Lesion, Radiofrequency
Applicant	NEUROTHERM, INC. 2 DEBUSH AVE. BUILDING A2 MIDDLETON, MA 01949 US Other 510(k) Applications for this Company
Contact	WILLIAM RITTMAN 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	10/12/2005
Decision Date	01/23/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review