FDA 510(k) Application Details - K053058

Device Classification Name Device, Nerve Conduction Velocity Measurement

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510(K) Number K053058
Device Name Device, Nerve Conduction Velocity Measurement
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 882.1550

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Classification Product Code JXE
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Date Received 10/31/2005
Decision Date 02/07/2006
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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