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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 K163509
Device Name XprESS ENT Dilation System
Applicant
Entellus Medical, Inc.
3600 Holly Lane N., Suite 40
Plymouth,  MN  55447
Applicant Contact Karen E. Peterson
Correspondent
Entellus Medical, Inc.
3600 Holly Lane N., Suite 40
Plymouth,  MN  55447
Correspondent Contact Karen E. Peterson
Regulation Number874.4180
Classification Product Code
PNZ  
Subsequent Product Code
LRC  
Date Received12/15/2016
Decision Date 04/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT02391584
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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