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FDA 510(k) Application Details - K070323
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
510(K) Number
K070323
Device Name
Clamp, Vascular
Applicant
VASCUTEK LTD.
NEWMAINS AVE.
INCHINNAN INDUSTRIAL ESTATE
RENFREWSHIRE,GLASGOW,SCOTLAND PA4 9RR GB
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Contact
KAREN KELSO
Other 510(k) Applications for this Contact
Regulation Number
870.4450
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Classification Product Code
DXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/02/2007
Decision Date
02/15/2007
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
Y
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