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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 K862377
Device Name QMED SELF ADHERING ELECTRODE
Applicant
Qmed, Inc.
3001 W. Kentucky St.
Louisville,  KY  40211
Applicant Contact LARRY D POTTS
Correspondent
Qmed, Inc.
3001 W. Kentucky St.
Louisville,  KY  40211
Correspondent Contact LARRY D POTTS
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/24/1986
Decision Date 09/26/1986
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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