FDA 510(k) Application Details - K113124

Device Classification Name Filter, Intravascular, Cardiovascular

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510(K) Number K113124
Device Name Filter, Intravascular, Cardiovascular
Applicant ALN IMPLANTS CHIRURGICAUX
2 RUE QUENOT
JARNAC 16200 FR
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Contact CYNTHIA COTTEREAU
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Regulation Number 870.3375

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Classification Product Code DTK
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Date Received 10/21/2011
Decision Date 11/09/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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