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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K862231
Device Name EMPI, MODEL 1000 HAND HELD ELECTRODE
Applicant
Empi
261 S. Commerce Circle
Minneapolis,  MN  55432
Applicant Contact GEORGE E MATHIESEN
Correspondent
Empi
261 S. Commerce Circle
Minneapolis,  MN  55432
Correspondent Contact GEORGE E MATHIESEN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/11/1986
Decision Date 08/27/1986
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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