K-number	K223542
Device name	TubaVent Balloon Dilatation System
Applicant	Spiggle & Theis Medizintechnik GmbH
Product code	PNZ
Device class	Class II
Decision date	Aug 3, 2023
Decision	Substantially Equivalent
Regulation	874.4180

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Source

View the full FDA submission: accessdata.fda.gov

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TubaVent Balloon Dilatation System

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