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FDA 510(k) Application Details - K012747
Device Classification Name
Probe, Blood-Flow, Extravascular
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510(K) Number
K012747
Device Name
Probe, Blood-Flow, Extravascular
Applicant
MEDTRONIC PERFUSION SYSTEMS
7611 NORTHLAND DR.
MINNEAPOLIS, MN 55038 US
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Contact
MARIE HOLM
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Regulation Number
870.2120
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Classification Product Code
DPT
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More FDA Info for this Product Code
Date Received
08/16/2001
Decision Date
09/14/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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