K-number	K183090
Device name	Relieva Tract Balloon Dilation System
Applicant	Acclarent, Inc.
Product code	QGK
Device class	Class I
Decision date	Apr 19, 2019
Decision	Substantially Equivalent
Regulation	874.4420

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Source

View the full FDA submission: accessdata.fda.gov

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Relieva Tract Balloon Dilation System

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