FDA 510(k) Application Details - K013005

Device Classification Name	Catheter, Ventricular   More FDA Info for this Device
510(K) Number	K013005
Device Name	Catheter, Ventricular
Applicant	INNERSPACE, INC. 2933 SOUTH PULLMAN ST., SUITE A SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	DONALD E BOBO 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	09/06/2001
Decision Date	03/08/2002
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