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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 K896766
Device Name TD-28 DISPOSABLE ELECTRODE
Applicant
Med USA
Box 47
East Fairfield,  VT  05448
Applicant Contact J. P AJA
Correspondent
Med USA
Box 47
East Fairfield,  VT  05448
Correspondent Contact J. P AJA
Regulation Number882.1320
Classification Product Code
GXY  
Date Received12/01/1989
Decision Date 03/14/1990
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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