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510(k) K183090

Relieva Tract Balloon Dilation System by Acclarent, Inc. — Product Code QGK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2019
Date Received
November 6, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon, Nasal Airway
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction.

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