FDA 510(k) Application Details - K955533

Device Classification Name	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter   More FDA Info for this Device
510(K) Number	K955533
Device Name	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Applicant	W.L. GORE & ASSOCIATES,INC 1505 N. FOURTH ST. POB 2200 FLAGSTAFF, AZ 86003-2200 US Other 510(k) Applications for this Company
Contact	TIMOTHY J RYNN Other 510(k) Applications for this Contact
Regulation Number	870.3450   More FDA Info for this Regulation Number
Classification Product Code	DYF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/1995
Decision Date	05/15/1996
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review