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FDA 510(k)

TRACHEOBRONXANE™ DUMON®

K-Number: K243126 · 2024-10-29

ApplicantNovatech SA
Decision Date2024-10-29
Product CodeNWA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRACHEOBRONXANE™ DUMON® is a medical device manufactured by Novatech SA. It received FDA 510(k) clearance on 2024-10-29 under approval number K243126. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACHEOBRONXANE™ DUMON®?

TRACHEOBRONXANE™ DUMON® is a medical device that received FDA 510(k) clearance on 2024-10-29. It is manufactured by Novatech SA. The 510(k) number is K243126.

When was TRACHEOBRONXANE™ DUMON® approved by the FDA?

TRACHEOBRONXANE™ DUMON® received FDA 510(k) clearance on 2024-10-29, under approval number K243126.

What company makes TRACHEOBRONXANE™ DUMON®?

TRACHEOBRONXANE™ DUMON® is manufactured by Novatech SA.

What is the FDA product code for TRACHEOBRONXANE™ DUMON®?

The FDA product code for TRACHEOBRONXANE™ DUMON® is NWA.

Other Devices by Novatech SA

Related Devices (Code: NWA)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.