Home / 510(k) Clearances / K203754

510(k) K203754

Eustachi Ear Pressure Relief Device by Exercore, LLC — Product Code MJV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 19, 2021
Date Received: December 23, 2020
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Device, Inflation, Middle Ear
Device Class: Class U
Regulation Number
Review Panel: EN
Submission Type