FDA 510(k) Application Details - K133987

Device Classification Name Snare, Flexible

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510(K) Number K133987
Device Name Snare, Flexible
Applicant Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact JANIS F TARANTO
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Regulation Number 876.4300

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Classification Product Code FDI
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Date Received 12/26/2013
Decision Date 01/24/2014
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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