FDA 510(k) Application Details - K041021

Device Classification Name	Probe, Radiofrequency Lesion   More FDA Info for this Device
510(K) Number	K041021
Device Name	Probe, Radiofrequency Lesion
Applicant	EPIMED INTERNATIONAL, INC. 141 SAL LANDRIO DR. CROSSROADS BUSINESS PARK JOHNSTOWN, NY 12095 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER B LAKE Other 510(k) Applications for this Contact
Regulation Number	882.4725   More FDA Info for this Regulation Number
Classification Product Code	GXI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2004
Decision Date	09/16/2004
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