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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K230320
Device Name NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
Applicant
Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville,  FL  32216
Applicant Contact Alexandra Oliver
Correspondent
Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville,  FL  32216
Correspondent Contact Emily Davis
Regulation Number874.1820
Classification Product Code
ETN  
Date Received02/06/2023
Decision Date 10/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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