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510(k) K252751

Earflo (EF001) by Earflo, Inc. — Product Code MJV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 10, 2026
Date Received: August 29, 2025
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