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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 K071349
Device Name NEUROSIGN LARYNGEAL ELECTRODES
Applicant
The Magstim Company , Ltd.
Spring Gardens, Whitland
Carmarthenshire,  GB SA34 OHR
Applicant Contact ANWEN EVANS
Correspondent
The Magstim Company , Ltd.
Spring Gardens, Whitland
Carmarthenshire,  GB SA34 OHR
Correspondent Contact ANWEN EVANS
Regulation Number874.1820
Classification Product Code
ETN  
Date Received05/14/2007
Decision Date 12/12/2007
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
Predetermined Change
Control Plan Authorized		 No
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