FDA 510(k) Application Details - K980148

Device Classification Name Stimulator, Nerve

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510(K) Number K980148
Device Name Stimulator, Nerve
Applicant THE MAGSTIM COMPANY LTD.
SPRING GARDENS, WHITLAND
DYFED, WALES SA34 OHR GB
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Contact CHRIS HOVEY
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Regulation Number 874.1820

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Classification Product Code ETN
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Date Received 01/15/1998
Decision Date 08/05/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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