TRACHEOBRONXANE DUMON®— 510(k) K243126

Substantially Equivalent

Novatech SA

FDA 510(k) clearance K243126 for TRACHEOBRONXANE DUMON®, Substantially Equivalent on 2024-10-29. Applicant: Novatech SA. Device class: 2.

Clearance details

Applicant: Novatech SA
Product code: Code NWA
Device class: Class 2
Regulation: 21 CFR 878.3720
Advisory panel: General, Plastic Surgery
Date received: 2024-09-30
Decision date: 2024-10-29
Decision: Substantially Equivalent
Clearance type: Special
Location: La Ciotat Cedex, FR

Download summary PDF View on FDA.gov ↗

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