K230065

Substantially Equivalent

VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System

Applicant: Fiagon GmbH
Product code: PNZ
Advisory panel: Ear, Nose, Throat
Date received: 2023-01-09
Decision date: 2023-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hennigsdorf, DE

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