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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 K970426
Device Name VALUETRODE
Applicant
AXELGAARD MFG. CO., LTD.
329 W. AVIATION RD.
fallbrook,  CA  92028 -3227
Applicant Contact dan jeffery
Correspondent
AXELGAARD MFG. CO., LTD.
329 W. AVIATION RD.
fallbrook,  CA  92028 -3227
Correspondent Contact dan jeffery
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/04/1997
Decision Date 05/09/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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