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510(k) K243126

Device
TRACHEOBRONXANE? DUMON®
Applicant
Novatech SA
510(k) number
K243126
Product code
NWA
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-29
Date received
2024-09-30
Regulation
878.3720
Classification name
Prosthesis, Tracheal, Preformed/Molded
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Montgomery Stuart K.
Address
Z.I. Athélia Iii -1058, Voie Antiope La Ciotat Cedex FR 13705 13705

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NWA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213969VisionAir Patient-Specific Airway StentNew Cos Inc. Dba Visionair Solutions2022-10-07
K182743Patient-Specific Airway StentNew Cos, Inc.2019-10-23
K971509ENDOXANENovatech SA1997-08-21
K894380DUMON TRACHEOBRONCHIAL STENTBryan Corp.1989-10-24
K873742HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESESHood Laboratories1987-10-01