K-number	K171761
Device name	ACCLARENT AERA Eustachian Tube Balloon Dilation System
Applicant	Acclarent, Inc.
Product code	PNZ
Device class	Class II
Decision date	Jan 16, 2018
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 Balloon Dilation System

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