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FDA 510(k) Application Details - K991899
Device Classification Name
Stimulator, Electrical, Evoked Response
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510(K) Number
K991899
Device Name
Stimulator, Electrical, Evoked Response
Applicant
NIHON KOHDEN AMERICA, INC.
2601 CAMPUS DR.
IRVINE, CA 92612-1601 US
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Contact
BONNIE BISHOP
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Regulation Number
882.1870
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Classification Product Code
GWF
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Date Received
06/04/1999
Decision Date
09/01/1999
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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