FDA 510(k) Application Details - K083538

Device Classification Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder

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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
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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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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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