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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 K091457
Device Name NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
Original Applicant
NEXSTIM OY
49 plain street
north attleboro,  MA  02760
Original Contact cynthia j nolte
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
HAW   IKN  
Date Received05/18/2009
Decision Date 12/08/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
statement statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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