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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 vibratory counter-stimulation
De Novo Number DEN110011
510(K) Number K102873
Device Name SYMPHONY DEVICE
Requester
sensory medical, inc
1235 puerta del sol #500
san clemente,  CA  92673
Contact fred burbank
Regulation Number882.5895
Classification Product Code
OVP  
Date Received07/13/2011
Decision Date 12/18/2013
Decision granted (DENG)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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