FDA 510(k) Application Details - K991683

Device Classification Name	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter   More FDA Info for this Device
510(K) Number	K991683
Device Name	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Applicant	W.L. GORE & ASSOCIATES,INC 3250 WEST KILTIE LN. P.O. BOX 2400 FLAGSTAFF, AZ 86001-0300 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	05/17/1999
Decision Date	09/08/1999
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