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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 K883781
Device Name NICOLET NEUROPORT/ACE SYSTEM
Applicant
Nicolet Instrument Corp.
5225 Verona Rd.
Madison,  WI  53711
Applicant Contact RAYMOND T RIDDLE
Correspondent
Nicolet Instrument Corp.
5225 Verona Rd.
Madison,  WI  53711
Correspondent Contact RAYMOND T RIDDLE
Regulation Number890.1375
Classification Product Code
IKN  
Date Received09/06/1988
Decision Date 06/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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