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FDA 510(k) Application Details - K133987
Device Classification Name
Snare, Flexible
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
876.4300
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Classification Product Code
FDI
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More FDA Info for this Product Code
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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