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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 K050469
Device Name EZ-STIK ELECTRODES
Applicant
NAIMCO, INC.
4120 SOUTH CREEK ROAD
CHATTANOOGA,  TN  37406
Applicant Contact ROBERT L MCCLURE
Correspondent
NAIMCO, INC.
4120 SOUTH CREEK ROAD
CHATTANOOGA,  TN  37406
Correspondent Contact ROBERT L MCCLURE
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/23/2005
Decision Date 05/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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