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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K860968
Device Name TM-3400, NOMAD (MODIFIED)
Applicant
Tracor Northern, Inc.
2551 W. Beltline Hwy.
Middleton,  WI  53562
Applicant Contact PATTY SONNTAG
Correspondent
Tracor Northern, Inc.
2551 W. Beltline Hwy.
Middleton,  WI  53562
Correspondent Contact PATTY SONNTAG
Regulation Number882.1870
Classification Product Code
GWF  
Date Received03/11/1986
Decision Date 08/18/1986
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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