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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 K061645
Device Name MAGPRO, MODEL R30
Applicant
Tonica Elektronik A/S
Lucernemarken 15
Farum,  DK
Applicant Contact LISE TERKELSEN
Correspondent
Tonica Elektronik A/S
Lucernemarken 15
Farum,  DK
Correspondent Contact LISE TERKELSEN
Regulation Number882.1870
Classification Product Code
GWF  
Date Received06/12/2006
Decision Date 10/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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