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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name upper extremity prosthesis with multiple simultaneous degrees of freedom and controlled via cutaneous electromyography
510(k) Number K121215
Device Name DEKA ARM SYSTEM
Original Applicant
DEKA INTEGRATED SOLUTIONS CORPORATION
340 commercial street
manchester,  NH  03101
Original Contact roger leroux
Regulation Number890.3450
Classification Product Code
PAE  
Date Received04/23/2012
Decision Date 05/09/2014
Decision de novo petitions granted (AN)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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