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FDA 510(k) Application Details - K230269
Device Classification Name
Prosthesis, Tracheal, Expandable
More FDA Info for this Device
510(K) Number
K230269
Device Name
Prosthesis, Tracheal, Expandable
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough, MA 01752 US
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Contact
Catherine Sanford
Other 510(k) Applications for this Contact
Regulation Number
878.3720
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Classification Product Code
JCT
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More FDA Info for this Product Code
Date Received
01/31/2023
Decision Date
07/14/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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