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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 K053141
Device Name NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800
Applicant
THE MAGSTIM COMPANY LTD.
SPRING GARDENS
WHITLAND, DYFED WALES,  GB SA34 OHR
Applicant Contact CHRIS LEWIS
Correspondent
THE MAGSTIM COMPANY LTD.
SPRING GARDENS
WHITLAND, DYFED WALES,  GB SA34 OHR
Correspondent Contact CHRIS LEWIS
Regulation Number874.1820
Classification Product Code
ETN  
Date Received11/09/2005
Decision Date 12/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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