K243126
- 510(k) number
- K243126
- Device name
- TRACHEOBRONXANE DUMON®
- Applicant
- Novatech SA FR
- Product code
- NWA — Prosthesis, Tracheal, Preformed/Molded
- Decision date
- 2024-10-29
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243126.pdf
Official FDA record: K243126
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.