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FDA 510(k) Application Details - K021144
Device Classification Name
Electrode, Cortical
More FDA Info for this Device
510(K) Number
K021144
Device Name
Electrode, Cortical
Applicant
NICOLET BIOMEDICAL, INC.
800 LEVANGER LN.
STOUGHTON, WI 53589 US
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Contact
Gary Syring
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Regulation Number
882.1310
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Classification Product Code
GYC
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More FDA Info for this Product Code
Date Received
04/09/2002
Decision Date
06/24/2002
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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