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FDA 510(k) Application Details - K052112
Device Classification Name
Electromyograph, Diagnostic
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.1375
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Classification Product Code
IKN
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More FDA Info for this Product Code
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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