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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 K980410
Device Name SLE ELECTRODES AND ACCESSORIES
Applicant
Specialized Laboratory Equipment, Ltd.
3407 Bay Ave.
Chico,  CA  95973
Applicant Contact FRANK FERGUSON
Correspondent
Specialized Laboratory Equipment, Ltd.
3407 Bay Ave.
Chico,  CA  95973
Correspondent Contact FRANK FERGUSON
Regulation Number882.1320
Classification Product Code
GXY  
Date Received02/03/1998
Decision Date 10/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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