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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 K020445
Device Name THE ELECTRODE STORE SURFACE (CUTANEOUS) ELECTRODE FOR EMG
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 Number882.1320
Classification Product Code
GXY  
Date Received02/11/2002
Decision Date 05/10/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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