FDA 510(k) Application Details - K142932

Device Classification Name Probe, Blood-Flow, Extravascular

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510(K) Number K142932
Device Name Probe, Blood-Flow, Extravascular
Applicant DELTEX MEDICAL LIMITED
TERMINUS RD.
CHICHESTER, WEST SUSSEX PO19 2TX GB
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Contact Paul Dwane
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Regulation Number 870.2120

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Classification Product Code DPT
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Date Received 10/09/2014
Decision Date 01/22/2015
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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