FDA 510(k) Application Details - K061269

Device Classification Name Electrode, Cutaneous

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510(K) Number K061269
Device Name Electrode, Cutaneous
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 882.1320

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Classification Product Code GXY
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Date Received 05/05/2006
Decision Date 08/14/2006
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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