FDA 510(k) Application Details - K032426

Device Classification Name Filter, Intravascular, Cardiovascular

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510(K) Number K032426
Device Name Filter, Intravascular, Cardiovascular
Applicant COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402-0489 US
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Contact JENNIFER J BOSLEY
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Regulation Number 870.3375

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Classification Product Code DTK
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Date Received 08/06/2003
Decision Date 10/31/2003
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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