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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, cortical
510(k) Number K173684
Device Name g.Estim PRO
Applicant
g.tec medical engineering GmbH
Siemingerstrasse 14
schiedlberg,  AU 4521
Applicant Contact christoph guger
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
new brighton,  MN  55112 -1891
Correspondent Contact olaf teichert
Regulation Number882.1310
Classification Product Code
GYC  
Date Received12/01/2017
Decision Date 05/04/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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