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FDA 510(k) K093934, GORE HYBRID VASCULAR GRAFT, by W.L. Gore & Associates

FDA 510(k) K093934, GORE HYBRID VASCULAR GRAFT, by W.L. Gore & Associates

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510(K) Number: K093934
Device Name: GORE HYBRID VASCULAR GRAFT
Manufacturer: W.L. Gore & Associates
Device Classification Name: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Regulation Number: 870.3450
Classification Product Code: DSY
Date Received: 12/22/2009
Decision Date: 03/17/2010
Regulation Medical Specialty: Cardiovascular
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