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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 K871292
Device Name HEALTH CONCEPTS CONDUCTIVE MEMBRANE
Applicant
Health Concepts, Inc.
Suite 334
511 Eleventh Ave. S.
Minneapolis,  MN  55415
Applicant Contact JIN SHIMADA
Correspondent
Health Concepts, Inc.
Suite 334
511 Eleventh Ave. S.
Minneapolis,  MN  55415
Correspondent Contact JIN SHIMADA
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/31/1987
Decision Date 06/02/1987
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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