FDA 510(k) Application Details - K020400

Device Classification Name Stimulator, Electrical, Evoked Response

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510(K) Number K020400
Device Name Stimulator, Electrical, Evoked Response
Applicant MEPS, LLC.
ONE EAST BROWARD BLVD #700
FORT LAUDERDALE, FL 33301 US
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Contact HARRY BENEDICT
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Regulation Number 882.1870

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Classification Product Code GWF
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Date Received 02/06/2002
Decision Date 08/23/2002
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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