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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurosurgical Nerve Locator
510(k) Number K203684
Device Name Neurosign V4 Intraoperative Nerve Monitor
Applicant
Magstim Company, Ltd.
Spring Gardens
Whitland,  GB SA340HR
Applicant Contact Rosie Hunt
Correspondent
Magstim Company, Ltd.
Spring Gardens
Whitland,  GB SA340HR
Correspondent Contact Tom Campbell
Regulation Number874.1820
Classification Product Code
PDQ  
Date Received12/17/2020
Decision Date 03/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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