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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 K020903
Device Name DOCXS B SERIES ELECTRODES
Applicant
Docxs, LLC
564 S. Dora, Suite A-1
Ukiah,  CA  95482
Applicant Contact RICHARD RIZZOLO
Correspondent
Docxs, LLC
564 S. Dora, Suite A-1
Ukiah,  CA  95482
Correspondent Contact RICHARD RIZZOLO
Regulation Number882.1320
Classification Product Code
GXY  
Date Received03/20/2002
Decision Date 09/26/2002
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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