K-number	K230742
Device name	ACCLARENT AERA Eustachian Tube Dilation System
Applicant	Acclarent, Inc.
Product code	PNZ
Device class	Class II
Decision date	Dec 13, 2023
Decision	Substantially Equivalent
Regulation	874.4180

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Source

View the full FDA submission: accessdata.fda.gov

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ACCLARENT AERA Eustachian Tube Dilation System

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