FDA 510(k) Application Details - K130536

Device Classification Name

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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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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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