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FDA 510(k) Application Details - K162794
Device Classification Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
More FDA Info for this Device
510(K) Number
K162794
Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Applicant
VASCUTEK LTD.
NEWMAINS AVENUE
INCHINNAN PA4 9RR GB
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Contact
NEIL MCLACHLAN
Other 510(k) Applications for this Contact
Regulation Number
870.3450
More FDA Info for this Regulation Number
Classification Product Code
DSY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/04/2016
Decision Date
06/30/2017
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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