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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conditioner, Signal, Physiological
510(k) Number K882599
Device Name NICOLET BRAINLAB 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 Number882.1845
Classification Product Code
GWK  
Date Received06/24/1988
Decision Date 10/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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