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FDA 510(k) Application Details - K130536
Device Classification Name
More FDA Info for this Device
510(K) Number
K130536
Device Name
EXPORT ADVANCE ASPIRATION CATHETER
Applicant
MEDTRONIC INC.
37A CHERRY HILL DRIVE
DANVERS, MA 01923 US
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Contact
COLLEEN MULLINS
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Regulation Number
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Classification Product Code
QEZ
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More FDA Info for this Product Code
Date Received
03/01/2013
Decision Date
07/16/2013
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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