FDA 510(k) Application Details - K093934

Device Classification Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter   More FDA Info for this Device
510(K) Number	K093934
Device Name	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant	W.L. GORE & ASSOCIATES 3250 W. KILTIE LANE FLAGSTAFF, AZ 86001 US Other 510(k) Applications for this Company
Contact	Michael Ivey 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	12/22/2009
Decision Date	03/17/2010
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