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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media, electroconductive
510(k) Number K022006
FOIA Releasable 510(k) K022006
Device Name CONDUCTIVE GEL
Applicant
THE DEZAC GROUP
719 A ST. NE
WASHINGTON,  DC  20002
Applicant Contact WENDY PARSLEY
Correspondent
THE DEZAC GROUP
719 A ST. NE
WASHINGTON,  DC  20002
Correspondent Contact WENDY PARSLEY
Regulation Number882.1275
Classification Product Code
GYB  
Date Received06/19/2002
Decision Date 09/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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