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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 K210841
Device Name NuVent Eustachian Tube Dilation Balloon
Applicant
Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville,  FL  32216
Applicant Contact Matthew Harmon
Correspondent
Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville,  FL  32216
Correspondent Contact Matthew Harmon
Regulation Number874.4180
Classification Product Code
PNZ  
Date Received03/22/2021
Decision Date 08/16/2021
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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