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FDA 510(k) Application Details - DEN070003
Device Classification Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
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510(K) Number
DEN070003
Device Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant
NEURONETICS
ONE GREAT VALLEY PKWY.
STE.2
MALVERN, PA 19355 US
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Contact
JUDY P WAYS
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Regulation Number
882.5805
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Classification Product Code
OBP
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More FDA Info for this Product Code
Date Received
05/24/2007
Decision Date
10/07/2008
Decision
DENG -
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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