FDA 510(k) Application Details - K100892

Device Classification Name Catheter, Continuous Flush

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510(K) Number K100892
Device Name Catheter, Continuous Flush
Applicant BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
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Contact Scott Sepple
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Regulation Number 870.1210

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Classification Product Code KRA
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Date Received 03/31/2010
Decision Date 04/12/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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