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FDA 510(k) Application Details - K034010
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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510(K) Number
K034010
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
Other 510(k) Applications for this Contact
Regulation Number
870.3450
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Classification Product Code
DSY
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More FDA Info for this Product Code
Date Received
12/24/2003
Decision Date
02/19/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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