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FDA 510(k) Application Details - K141124
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
More FDA Info for this Device
510(K) Number
K141124
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
VASCULAR FLOW TECHNOLOGIES LTD
Prospect Business Centre
Gemini Cresent, Dundee Technology Park
Dundee DD2 1TY GB
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Contact
EDWIN LINDSAY
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
05/01/2014
Decision Date
05/30/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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