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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 K991583
Device Name NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR
Applicant
THE MAGSTIM COMPANY LTD.
730 FIFTH AVE, 9TH FLOOR
NEW YORK,  NY  10019
Applicant Contact REZA JALINOUS
Correspondent
THE MAGSTIM COMPANY LTD.
730 FIFTH AVE, 9TH FLOOR
NEW YORK,  NY  10019
Correspondent Contact REZA JALINOUS
Regulation Number874.1820
Classification Product Code
ETN  
Date Received05/07/1999
Decision Date 05/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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