FDA 510(k) Application Details - K002389

Device Classification Name	Probe, Radiofrequency Lesion   More FDA Info for this Device
510(K) Number	K002389
Device Name	Probe, Radiofrequency Lesion
Applicant	BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 5 MISSISSAUGA L4W-4T7 CA Other 510(k) Applications for this Company
Contact	KRIS SHAH 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	08/04/2000
Decision Date	10/23/2000
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