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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 K020468
Device Name CHIN ELECTRODE
Applicant
DYMEDIX, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Applicant Contact Gary Syring
Correspondent
DYMEDIX, INC.
800 LEVANGER LN.
STOUGHTON,  WI  53589
Correspondent Contact Gary Syring
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/12/2002
Decision Date 04/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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