FDA 510(k) Application Details - DEN110011

Device Classification Name

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510(K) Number DEN110011
Device Name SYMPHONY DEVICE
Applicant SENSORY MEDICAL, INC
1235 PUERTA DEL SOL #500
SAN CLEMENTE, CA 92673 US
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Contact FRED BURBANK
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Regulation Number

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Classification Product Code OVP
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Date Received 07/13/2011
Decision Date 12/18/2013
Decision DENG -
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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