Relieva Tract Balloon Dilation System— 510(k) K183090

Substantially Equivalent

Acclarent, Inc.

FDA 510(k) clearance K183090 for Relieva Tract Balloon Dilation System, Substantially Equivalent on 2019-04-19. Applicant: Acclarent, Inc..

Clearance details

Applicant: Acclarent, Inc.
Product code: Code QGK
Advisory panel: Ear, Nose, Throat
Date received: 2018-11-06
Decision date: 2019-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvin, CA, US

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