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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 K082614
Device Name EVOX ELECTRO DIAGNOSTIC DEVICE
Applicant
LABORIE MEDICAL TECHNOLOGIES, INC.
400 AVENUE D SUITE 10
WILLISTON,  VT  05495
Applicant Contact BARBARA MORNET
Correspondent
LABORIE MEDICAL TECHNOLOGIES, INC.
400 AVENUE D SUITE 10
WILLISTON,  VT  05495
Correspondent Contact BARBARA MORNET
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Code
JXE  
Date Received09/09/2008
Decision Date 03/06/2009
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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