FDA 510(k) Application Details - K034050

Device Classification Name Filter, Intravascular, Cardiovascular

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510(K) Number K034050
Device Name Filter, Intravascular, Cardiovascular
Applicant CORDIS CORPORATION
7 POWDER HORN DRIVE
WARREN, NJ 07059 US
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Contact DONNA MARSHALL
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Regulation Number 870.3375

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Classification Product Code DTK
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Date Received 12/30/2003
Decision Date 03/22/2004
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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