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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Electroconductive
510(k) Number K904377
Device Name ELECTROCONDUCTIVE MEDIA
Applicant
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Applicant Contact ERNEST HENLEY
Correspondent
Henley Intl.
104 Industrial Blvd.,
Sugar Land,  TX  77470
Correspondent Contact ERNEST HENLEY
Regulation Number882.1275
Classification Product Code
GYB  
Date Received09/24/1990
Decision Date 11/15/1991
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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