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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 K213246
Device Name NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
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 Alexandra Oliver
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/30/2021
Decision Date 03/21/2022
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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