FDA 510(k) Application Details - K061727

Device Classification Name	Vessel Guard Or Cover, To Facilitate Revision Surgeries   More FDA Info for this Device
510(K) Number	K061727
Device Name	Vessel Guard Or Cover, To Facilitate Revision Surgeries
Applicant	W.L. GORE & ASSOCIATES,INC 1505 NORTH FOURTH ST. FLAGSTAFF, AZ 86003-3000 US Other 510(k) Applications for this Company
Contact	Michael Ivey Other 510(k) Applications for this Contact
Regulation Number	870.3470   More FDA Info for this Regulation Number
Classification Product Code	MFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2006
Decision Date	08/07/2006
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