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FDA 510(k) Application Details - K061269
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
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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More FDA Info for this Product Code
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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