FDA 510(k) Application Details - K040492

Device Classification Name Catheter, Hemodialysis, Implanted

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510(K) Number K040492
Device Name Catheter, Hemodialysis, Implanted
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact NICHOLAS CONDAKES
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Regulation Number 876.5540

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Classification Product Code MSD
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Date Received 02/26/2004
Decision Date 03/16/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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