FDA 510(k) Application Details - K120006

Device Classification Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter   More FDA Info for this Device
510(K) Number	K120006
Device Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant	HEMOSPHERE INC 6545 CITY WEST PARKWAY EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	LAURIE LYNCH Other 510(k) Applications for this Contact
Regulation Number	870.3450   More FDA Info for this Regulation Number
Classification Product Code	DSY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2012
Decision Date	02/02/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review