FDA 510(k) Application Details - K024316

Device Classification Name Electromyograph, Diagnostic

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510(K) Number K024316
Device Name Electromyograph, Diagnostic
Applicant MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216 US
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Contact MARTIN SARGENT
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Regulation Number 890.1375

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Classification Product Code IKN
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Date Received 12/26/2002
Decision Date 01/06/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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