FDA 510(k) Application Details - K053141

Device Classification Name Stimulator, Nerve

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510(K) Number K053141
Device Name Stimulator, Nerve
Applicant THE MAGSTIM COMPANY LTD.
SPRING GARDENS
WHITLAND, DYFED WALES SA34 OHR GB
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Contact CHRIS LEWIS
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Regulation Number 874.1820

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Classification Product Code ETN
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Date Received 11/09/2005
Decision Date 12/14/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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