FDA 510(k) Application Details - K132730

Device Classification Name Probe, Blood-Flow, Extravascular

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510(K) Number K132730
Device Name Probe, Blood-Flow, Extravascular
Applicant MEDTRONIC INC.
7611 NORTHLAND DRIVE
MINNEAPOLIS, MN 55428 US
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Contact JESSICA SIXBERRY
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Regulation Number 870.2120

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Classification Product Code DPT
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Date Received 09/03/2013
Decision Date 05/30/2014
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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