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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cortical
510(k) Number K923330
Device Name THE WESTERN CORTICAL ELECTRODE ARRAY
Applicant
UNIVERSITY HOSPITAL (LONDON) DEVELOPMENT CORP.
150 DUFFERIN AVENUE
SUITE 900
LONDON ONTARIO N6A 5N6,  CA
Applicant Contact BOB GRAVETT
Correspondent
UNIVERSITY HOSPITAL (LONDON) DEVELOPMENT CORP.
150 DUFFERIN AVENUE
SUITE 900
LONDON ONTARIO N6A 5N6,  CA
Correspondent Contact BOB GRAVETT
Regulation Number882.1310
Classification Product Code
GYC  
Date Received07/07/1992
Decision Date 11/09/1993
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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