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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 K943009
Device Name SMD ELECTRODES
Applicant
Scientific Medical Devices, Inc.
562 Lakeland Plz.
Suite 256
Cumming,  GA  30130
Applicant Contact KENT H KOHNKEN
Correspondent
Scientific Medical Devices, Inc.
562 Lakeland Plz.
Suite 256
Cumming,  GA  30130
Correspondent Contact KENT H KOHNKEN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/24/1994
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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