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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Eustachian Tube Balloon Dilation Device
510(k) Number K220027
Device Name Audion ET dilation system
Applicant
Entellus Medical, Inc.
3600 Holly Lane North, Suite 40
Plymouth,  MN  55447
Applicant Contact Katie Wilson
Correspondent
Entellus Medical, Inc.
3600 Holly Lane North, Suite 40
Plymouth,  MN  55447
Correspondent Contact Katie Wilson
Regulation Number874.4180
Classification Product Code
PNZ  
Date Received01/05/2022
Decision Date 04/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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