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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 K231580
Device Name NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
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 Gabriela Moreira
Regulation Number874.1820
Classification Product Code
ETN  
Date Received05/31/2023
Decision Date 08/30/2023
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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