FDA 510(k) Application Details - K110479

Device Classification Name Wire, Guide, Catheter

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510(K) Number K110479
Device Name Wire, Guide, Catheter
Applicant BOSTON SCIENTIFIC CORP.
4100 HAMLINE AVE NORTH
ST. PAUL, MN 55112 US
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Contact KIRSTIN JOHNSTON
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 02/18/2011
Decision Date 04/08/2011
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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