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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Inflation, Middle Ear
510(k) Number K203754
Device Name Eustachi Ear Pressure Relief Device
Applicant
Exercore, LLC
8170 Old Carriage Court N, Suite 200
Shakopee,  MN  55379
Applicant Contact Kevin Connelly
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1840
Minneapolis,  MN  55402
Correspondent Contact Lisa Pritchard
Classification Product Code
MJV  
Date Received12/23/2020
Decision Date 02/19/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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