FDA 510(k) Application Details - K033050

Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording

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510(K) Number K033050
Device Name Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS, MN 55432-3576 US
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Contact MAC MCKEEN
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Regulation Number 870.1220

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Classification Product Code DRF
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Date Received 09/29/2003
Decision Date 03/26/2004
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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