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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Needle
510(k) Number K020910
Device Name SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
Applicant
THE ELECTRODE STORE, INC.
936-11TH AVENUE EAST
SEATTLE,  WA  98102
Applicant Contact CARL YOUNGMANN
Correspondent
THE ELECTRODE STORE, INC.
936-11TH AVENUE EAST
SEATTLE,  WA  98102
Correspondent Contact CARL YOUNGMANN
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received03/20/2002
Decision Date 07/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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