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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 K992313
Device Name XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16
Applicant
Excel Tech. , Ltd.
2892 Portland Dr.
Oakville,Ontario,  CA L6H 5W8
Applicant Contact JOHN R MUMFORD
Correspondent
Excel Tech. , Ltd.
2892 Portland Dr.
Oakville,Ontario,  CA L6H 5W8
Correspondent Contact JOHN R MUMFORD
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWE   GWJ   GWQ  
Date Received07/09/1999
Decision Date 08/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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