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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 K860903
Device Name TM-3600 A NEURODIAGNOSTIC SYSTEM
Applicant
TRACOR NORTHERN, INC.
2551 WEST BELTLINE HWY
MIDDLETON,  WI  53562
Applicant Contact PATTY SONNTAG
Correspondent
TRACOR NORTHERN, INC.
2551 WEST BELTLINE HWY
MIDDLETON,  WI  53562
Correspondent Contact PATTY SONNTAG
Regulation Number882.1870
Classification Product Code
GWF  
Date Received03/10/1986
Decision Date 06/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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