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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 K944314
Device Name DISPOSABLE TM-E COCHGTRODE - BLSC PART NO. 101123
Applicant
Bio-Logic Systems Corp.
One Bio-Logic Plaza
Mundelein,  IL  60060 -3700
Applicant Contact RON ROLFSEN
Correspondent
Bio-Logic Systems Corp.
One Bio-Logic Plaza
Mundelein,  IL  60060 -3700
Correspondent Contact RON ROLFSEN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/29/1994
Decision Date 01/03/1996
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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