FDA 510(k) Application Details - K070514

Device Classification Name Filter, Intravascular, Cardiovascular

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510(K) Number K070514
Device Name Filter, Intravascular, Cardiovascular
Applicant ALN IMPLANTS CHIRURGICAUX
900 CIRCLE 75 PKWY.
SUITE 1240
ATLANTA, GA 30339 US
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Contact DAVE PARENTE
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Regulation Number 870.3375

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Classification Product Code DTK
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Date Received 02/22/2007
Decision Date 01/30/2008
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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