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FDA 510(k) Application Details - K133408
Device Classification Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
More FDA Info for this Device
510(K) Number
K133408
Device Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant
NEURONETICS
3222 PHOENIXVILLE PIKE
MALVERN, PA 19355-1245 US
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Contact
JUDY P WAYS, PH.D.
Other 510(k) Applications for this Contact
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
11/06/2013
Decision Date
03/28/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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