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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K123795
Device Name AXON-BUS PROSTHETIC SYSTEM
Applicant
Otto Bock Austria
Kaiserstrasse 39
Vienna,  AT A-1070
Applicant Contact REINHARD WOLKERSTORFER
Correspondent
Otto Bock Austria
Kaiserstrasse 39
Vienna,  AT A-1070
Correspondent Contact REINHARD WOLKERSTORFER
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
IQZ  
Date Received12/10/2012
Decision Date 06/03/2014
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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