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FDA 510(k) Application Details - K123571
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
510(K) Number
K123571
Device Name
Clamp, Vascular
Applicant
CARDIOMEDICAL GMBH
AMSTEL 320-1
AMSTERDAM, NOORD-HOLLAND 1017AP NL
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Contact
ANGELIKA SCHERP
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
11/20/2012
Decision Date
08/01/2013
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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