FDA 510(k) Application Details - K012365

Device Classification Name Catheter, Hemodialysis, Implanted

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510(K) Number K012365
Device Name Catheter, Hemodialysis, Implanted
Applicant BOSTON SCIENTIFIC CORP.
One Boston Scientific Place
Natick, MA 01760 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 07/26/2001
Decision Date 08/24/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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