FDA 510(k) Application Details - K143531

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

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510(K) Number K143531
Device Name Repetitive Transcranial Magnetic Stimulator For Treatment Of Major Depressive Disorder
Applicant MAGSTIM COMPANY LIMITED
SPRING GARDENS, WHITLAND
CARMARTHENSHIRE SA34 OHR GB
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Contact Charles Hounsell
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Regulation Number 882.5805

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Classification Product Code OBP
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Date Received 12/12/2014
Decision Date 05/08/2015
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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