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FDA 510(k) Application Details - DEN110011
Device Classification Name
More FDA Info for this Device
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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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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