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FDA 510(k) Application Details - K071446
Device Classification Name
Electrode, Cutaneous
More FDA Info for this Device
510(K) Number
K071446
Device Name
Electrode, Cutaneous
Applicant
ELECTRODE ARRAYS
612 N. RESLER
EL PASO, TX 79912 US
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Contact
ELVIRA GARCIA
Other 510(k) Applications for this Contact
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
05/24/2007
Decision Date
07/02/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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