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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 K130987
Device Name VALUTRODE NEUROSTIMLATION ELECTRODES
Applicant
Axelgaard Mfg. Co., Ltd.
520 Industrial Way
Fallbrook,  CA  92028
Applicant Contact DAN P JEFFERY
Correspondent
Axelgaard Mfg. Co., Ltd.
520 Industrial Way
Fallbrook,  CA  92028
Correspondent Contact DAN P JEFFERY
Regulation Number882.1320
Classification Product Code
GXY  
Date Received04/09/2013
Decision Date 07/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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