FDA 510(k) Application Details - K103080

Device Classification Name	Graft, Vascular, Synthetic/Biologic Composite   More FDA Info for this Device
510(K) Number	K103080
Device Name	Graft, Vascular, Synthetic/Biologic Composite
Applicant	LEMAITRE VASCULAR, INC. 63 2ND AVENUE BURLINGTON, MA 01803 US Other 510(k) Applications for this Company
Contact	ANDREW HODGKINSON Other 510(k) Applications for this Contact
Regulation Number	870.3450   More FDA Info for this Regulation Number
Classification Product Code	MAL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2010
Decision Date	01/19/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review