FDA 510(k) Application Details - K021144

Device Classification Name Electrode, Cortical

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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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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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