FDA 510(k) Application Details - K010485

Device Classification Name Filter, Intravascular, Cardiovascular

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510(K) Number K010485
Device Name Filter, Intravascular, Cardiovascular
Applicant B BRAUN
2934 CENTRAL STREET, SUITE 1A
EVANSTON, IL 60201 US
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Contact PAUL O'CONNELL
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Regulation Number 870.3375

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Classification Product Code DTK
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Date Received 02/20/2001
Decision Date 05/18/2001
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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