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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
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