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FDA 510(k) Application Details - K040869
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
QEZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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