FDA 510(k) Application Details - K932994

Device Classification Name Stimulator, Electrical, Evoked Response

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510(K) Number K932994
Device Name Stimulator, Electrical, Evoked Response
Applicant NEUROMEDICAL SYSTEMS, INC.
12101 COUNTY LINE RD.
CHESTERLAND, OH 44026 US
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Contact CHARLES MANNING
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Regulation Number 882.1870

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Classification Product Code GWF
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Date Received 06/18/1993
Decision Date 04/15/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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