FDA 510(k) Application Details - K141124

Device Classification Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

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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
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Regulation Number 870.3450

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Classification Product Code DSY
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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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