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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
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