FDA 510(k) Application Details - K040869

Device Classification Name

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510(K) Number K040869
Device Name EXPORT CATHETER
Applicant MEDTRONIC VASCULAR
37A CHERRY HILL DR.
DANVERS, MA 01923 US
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Contact FRED L BOUCHER
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Regulation Number

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Classification Product Code QEZ
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Date Received 04/02/2004
Decision Date 06/01/2004
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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