FDA 510(k) Application Details - K230269

Device Classification Name Prosthesis, Tracheal, Expandable

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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
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Regulation Number 878.3720

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Classification Product Code JCT
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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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