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FDA 510(k) Application Details - K072364
Device Classification Name
Probe, Thermodilution
More FDA Info for this Device
510(K) Number
K072364
Device Name
Probe, Thermodilution
Applicant
PULSION MEDICAL SYSTEMS AG
7220 SPARHAWK RD.
WAKE FOREST, NC 27587 US
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Contact
Jamie Sulley
Other 510(k) Applications for this Contact
Regulation Number
870.1915
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Classification Product Code
KRB
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More FDA Info for this Product Code
Date Received
08/22/2007
Decision Date
09/19/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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