FDA 510(k) Application Details - K060847

Device Classification Name Stimulator, Electrical, Evoked Response

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510(K) Number K060847
Device Name Stimulator, Electrical, Evoked Response
Applicant MAGSTIM COMPANY US, LLC.
304 CAMBRIDGE RD
SUITE 502
WOBURN, MA 01801 US
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Contact REZA JALINOUS
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Regulation Number 882.1870

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Classification Product Code GWF
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Date Received 03/28/2006
Decision Date 09/26/2006
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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