FDA 510(k) Application Details - K955396

Device Classification Name Filter, Intravascular, Cardiovascular

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510(K) Number K955396
Device Name Filter, Intravascular, Cardiovascular
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact LAURA MONDANO
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Regulation Number 870.3375

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Classification Product Code DTK
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Date Received 11/24/1995
Decision Date 02/09/1996
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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