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FDA 510(k) Application Details - K051178
Device Classification Name
Stimulator, Electrical, Evoked Response
More FDA Info for this Device
510(K) Number
K051178
Device Name
Stimulator, Electrical, Evoked Response
Applicant
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH, CA 92610-1601 US
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Contact
SERRAH NAMINI
Other 510(k) Applications for this Contact
Regulation Number
882.1870
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Classification Product Code
GWF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/09/2005
Decision Date
08/17/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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