FDA 510(k) Application Details - K063217

Device Classification Name Filter, Intravascular, Cardiovascular

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510(K) Number K063217
Device Name Filter, Intravascular, Cardiovascular
Applicant B. BRAUN MEDICAL, INC.
824 TWELFTH AVE.
BETHLEHEM, PA 18018 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 10/24/2006
Decision Date 01/12/2007
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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