FDA 510(k) Application Details - K030999

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

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510(K) Number K030999
Device Name Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant VASCUTEK LTD.
6200 JACKSON RD.
ANN ARBOR, MI 48103-9300 US
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Contact STEVEN ARICK
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Regulation Number 870.3450

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Classification Product Code DSY
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Date Received 03/31/2003
Decision Date 04/09/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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