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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nystagmograph
510(k) Number K851190
Device Name NYSTAGMOGRAPH EOG/ENG ANALYSES
Applicant
Nicolet Biomedical Instruments
5225-4 Verona Rd.
P.O. Box 4287
Madison,  WI  53711
Applicant Contact RON LUICH
Correspondent
Nicolet Biomedical Instruments
5225-4 Verona Rd.
P.O. Box 4287
Madison,  WI  53711
Correspondent Contact RON LUICH
Regulation Number882.1460
Classification Product Code
GWN  
Date Received03/26/1985
Decision Date 11/27/1985
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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