FDA 510(k) Application Details - K041528

Device Classification Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter   More FDA Info for this Device
510(K) Number	K041528
Device Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant	VASCUTEK LTD. 6200 JACKSON RD. ANN ARBOR, MI 48103-9300 US Other 510(k) Applications for this Company
Contact	STEVEN ARICK 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	06/08/2004
Decision Date	09/14/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review