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FDA 510(k) Application Details - K094044
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
More FDA Info for this Device
510(K) Number
K094044
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
TAYSIDE FLOW TECHNOLOGIES LIMITED
1141 E. HAWKEN WAY
CHANDLER, AZ 85286 US
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Contact
RUDY MOUNIA
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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
12/31/2009
Decision Date
03/23/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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