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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 K943126
Device Name ELECTROFLEX
Applicant
Medical Devices, Inc.
833 Third St. Southwest
St. Paul,  MN  55112
Applicant Contact DAVID KAYSEN
Correspondent
Medical Devices, Inc.
833 Third St. Southwest
St. Paul,  MN  55112
Correspondent Contact DAVID KAYSEN
Regulation Number882.1320
Classification Product Code
GXY  
Date Received06/29/1994
Decision Date 12/05/1994
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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