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FDA 510(k) Application Details - K112034
Device Classification Name
Electrode, Needle, Diagnostic Electromyograph
More FDA Info for this Device
510(K) Number
K112034
Device Name
Electrode, Needle, Diagnostic Electromyograph
Applicant
CAREFUSION 209, INC.
1850 Deming Way
Middleton, WI 53562 US
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Contact
GLEN HERMANSON
Other 510(k) Applications for this Contact
Regulation Number
890.1385
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Classification Product Code
IKT
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More FDA Info for this Product Code
Date Received
07/15/2011
Decision Date
08/12/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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