FDA 510(k) Application Details - K052112

Device Classification Name Electromyograph, Diagnostic

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510(K) Number K052112
Device Name Electromyograph, Diagnostic
Applicant EXCEL TECH. LTD.
2568 BRISTOL CIRCLE
OAKVILLE, ONTARIO L6H 5S1 CA
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Contact NICOLE LANDREVILLE
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Regulation Number 890.1375

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Classification Product Code IKN
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Date Received 08/04/2005
Decision Date 10/28/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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