FDA 510(k) Application Details - K080901

Device Classification Name	More FDA Info for this Device
510(K) Number	K080901
Device Name	LBI EMBOLECTOMY SYSTEM
Applicant	LUMEN BIOMEDICAL, INC. 14505 21ST AVE. NORTH SUITE 212 PLYMOUTH, MN 55447 US Other 510(k) Applications for this Company
Contact	MARIA E BRITTLE Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2008
Decision Date	10/02/2008
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review