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FDA 510(k) Application Details - K981405
Device Classification Name
Stimulator, Electrical, Evoked Response
More FDA Info for this Device
510(K) Number
K981405
Device Name
Stimulator, Electrical, Evoked Response
Applicant
OXFORD INSTRUMENTS, PLC.
MANOR WAY
OLD WOKING , SURREY 9022 0JU GB
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Contact
JEFF HALL
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Regulation Number
882.1870
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Classification Product Code
GWF
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More FDA Info for this Product Code
Date Received
04/20/1998
Decision Date
07/16/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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