FDA 510(k) Application Details - K001678

Device Classification Name	Device, Neurovascular Embolization   More FDA Info for this Device
510(K) Number	K001678
Device Name	Device, Neurovascular Embolization
Applicant	SURGICA CORP. 5090 ROBERT J. MATHEWS PKWY. #4 EL DORADO HILLS, CA 95762 US Other 510(k) Applications for this Company
Contact	LOU MATSON Other 510(k) Applications for this Contact
Regulation Number	882.5950   More FDA Info for this Regulation Number
Classification Product Code	HCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2000
Decision Date	01/25/2001
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