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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle, Diagnostic Electromyograph
510(k) Number K011818
Device Name STERILE EMG ELECTRODES
Applicant
NICOLET BIOMEDICAL, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
NICOLET BIOMEDICAL, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Correspondent Contact Gary Syring
Regulation Number890.1385
Classification Product Code
IKT  
Subsequent Product Code
GXZ  
Date Received06/11/2001
Decision Date 09/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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