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FDA 510(k) Application Details - K011818
Device Classification Name
Electrode, Needle, Diagnostic Electromyograph
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510(K) Number
K011818
Device Name
Electrode, Needle, Diagnostic Electromyograph
Applicant
NICOLET BIOMEDICAL, INC.
800 LEVANGER LN.
STOUGHTON, WI 53589 US
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Contact
Gary Syring
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Regulation Number
890.1385
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Classification Product Code
IKT
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More FDA Info for this Product Code
Date Received
06/11/2001
Decision Date
09/06/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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