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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 K965065
Device Name TECA. MILLENNIUM
Applicant
MEDELEC LTD.
MANOR WAY
OLD WOKING
SURREY, ENGLAND GU22 9JU,  GB
Applicant Contact JEFF HALL
Correspondent
MEDELEC LTD.
MANOR WAY
OLD WOKING
SURREY, ENGLAND GU22 9JU,  GB
Correspondent Contact JEFF HALL
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
GWE   GWJ   IKN   JXE  
Date Received12/18/1996
Decision Date 06/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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