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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, electrical, evoked response
510(k) Number K130403
Device Name MAGSTIM DOUBLE 70-2 COIL
Applicant
THE MAGSTIM COMPANY LTD.
101 MILK ST.
METHUEN,  MA  01844
Applicant Contact J. P OUELLETTE
Correspondent
THE MAGSTIM COMPANY LTD.
101 MILK ST.
METHUEN,  MA  01844
Correspondent Contact J. P OUELLETTE
Regulation Number882.1870
Classification Product Code
GWF  
Date Received02/19/2013
Decision Date 08/23/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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