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FDA 510(k) Application Details - K083538
Device Classification Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
More FDA Info for this Device
510(K) Number
K083538
Device Name
Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant
NEURONETICS
ONE GREAT VALLEY PKWY.
STE.2
MALVERN, PA 19355 US
Other 510(k) Applications for this Company
Contact
JUDY P WAYS
Other 510(k) Applications for this Contact
Regulation Number
882.5805
More FDA Info for this Regulation Number
Classification Product Code
OBP
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More FDA Info for this Product Code
Date Received
11/28/2008
Decision Date
12/16/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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