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FDA 510(k) Application Details - K231549
Device Classification Name
More FDA Info for this Device
510(K) Number
K231549
Device Name
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 US
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Contact
Jotham Moon
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Regulation Number
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Classification Product Code
OTN
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Date Received
05/30/2023
Decision Date
06/29/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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