FDA 510(k) Application Details - K021481

Device Classification Name	Catheter, Ventricular   More FDA Info for this Device
510(K) Number	K021481
Device Name	Catheter, Ventricular
Applicant	BRESAGEN, INC. 111 RIVER BEND RD. ATHENS, GA 30605 US Other 510(k) Applications for this Company
Contact	JOHN KUCHARCZYK Other 510(k) Applications for this Contact
Regulation Number	882.4100   More FDA Info for this Regulation Number
Classification Product Code	HCA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2002
Decision Date	08/06/2002
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