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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 K941986
Device Name CUTANEOUS ELECTRODE
Applicant
Maxxim Medical
104 Industrial Blvd.
Sugar Land,  TX  77478
Applicant Contact ERNEST J HENLEY, PH.D
Correspondent
Maxxim Medical
104 Industrial Blvd.
Sugar Land,  TX  77478
Correspondent Contact ERNEST J HENLEY, PH.D
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/25/1994
Decision Date 02/21/1995
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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