FDA 510(k) Application Details - K003964

Device Classification Name Filter, Intravascular, Cardiovascular

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510(K) Number K003964
Device Name Filter, Intravascular, Cardiovascular
Applicant CORDIS CORP.
7 POWDER HORN DR.
WARREN, NJ 07059 US
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Contact KAREN WILK
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Regulation Number 870.3375

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Classification Product Code DTK
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Date Received 12/22/2000
Decision Date 01/19/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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