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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electromyograph, diagnostic
510(k) Number K830702
Device Name NICOLET EMG SATELLITE
Applicant
NICOLET BIOMEDICAL INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
NICOLET BIOMEDICAL INSTRUMENTS
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number890.1375
Classification Product Code
IKN  
Date Received03/07/1983
Decision Date 07/12/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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