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510(k) K243126

TRACHEOBRONXANE DUMON® by Novatech SA — Product Code NWA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 29, 2024
Date Received: September 30, 2024
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prosthesis, Tracheal, Preformed/Molded
Device Class: Class II
Regulation Number: 878.3720
Review Panel: AN
Submission Type

The device is intended to provide support to weakened or constricting airway walls.