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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 K992911
Device Name MAGSTIM RAPID
Applicant
Magstim Corporation US
730 Fifth Ave.
9th Floor
New York,  NY  10019
Applicant Contact REZA JALINOUS
Correspondent
Magstim Corporation US
730 Fifth Ave.
9th Floor
New York,  NY  10019
Correspondent Contact REZA JALINOUS
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Code
JXE  
Date Received08/30/1999
Decision Date 01/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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