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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name upper extremity prosthesis with multiple simultaneous degrees of freedom and controlled via cutaneous electromyography
De Novo Number DEN120016
510(K) Number K121215
Device Name DEKA ARM SYSTEM
Requester
DEKA INTEGRATED SOLUTIONS CORPORATION
340 commercial street
manchester,  NH  03101
Contact roger leroux
Regulation Number890.3450
Classification Product Code
PAE  
Date Received06/15/2012
Decision Date 05/09/2014
Decision granted (DENG)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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