K-number	K210841
Device name	NuVent Eustachian Tube Dilation Balloon
Applicant	Medtronic Xomed, Inc.
Product code	PNZ
Device class	Class II
Decision date	Aug 16, 2021
Decision	Substantially Equivalent
Regulation	874.4180

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Source

View the full FDA submission: accessdata.fda.gov

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NuVent Eustachian Tube Dilation Balloon

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