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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ent Manual Surgical
510(k) Number K152121
Device Name NuVent EM Sinus Dilation System
Applicant
Medtronic Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Applicant Contact Gabriela Anchondo
Correspondent
Medtronic Xomed, Inc.
6743 Southpoint Dr. N.
Jacksonville,  FL  32216
Correspondent Contact Gabriela Anchondo
Regulation Number874.4420
Classification Product Code
LRC  
Date Received07/30/2015
Decision Date 12/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT02284347
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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