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FDA 510(k) Application Details - K141820
Device Classification Name
Endoscopic Guidewire, Gastroenterology-Urology
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510(K) Number
K141820
Device Name
Endoscopic Guidewire, Gastroenterology-Urology
Applicant
BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact
ALLISON BAILLIE
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Regulation Number
876.1500
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Classification Product Code
OCY
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Date Received
07/07/2014
Decision Date
10/21/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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