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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K002969
Device Name XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-8
Applicant
Xltek
2568 Bristol Circle
Oakville,  CA L6H 5S1
Applicant Contact DEBBIE DAVY
Correspondent
Xltek
2568 Bristol Circle
Oakville,  CA L6H 5S1
Correspondent Contact DEBBIE DAVY
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWE   GWJ   GWQ   IKN  
Date Received09/22/2000
Decision Date 12/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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