K-number	K213969
Device name	VisionAir Patient-Specific Airway Stent
Applicant	New Cos Inc. Dba Visionair Solutions
Product code	NWA
Device class	Class II
Decision date	Oct 7, 2022
Decision	Substantially Equivalent
Regulation	878.3720

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Source

View the full FDA submission: accessdata.fda.gov

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VisionAir Patient-Specific Airway Stent

Everything you need for a 510(k) submission. Nothing you don't.