FDA 510(k) Application Details - K120884

Device Classification Name Probe, Blood-Flow, Extravascular

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510(K) Number K120884
Device Name Probe, Blood-Flow, Extravascular
Applicant PERIMED AB
DATAVAGEN 9 A
JARFALLA 17543 SE
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Contact MARIA LILJEVRET
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Regulation Number 870.2120

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Classification Product Code DPT
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Date Received 03/23/2012
Decision Date 07/03/2012
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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