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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K142567
Device Name RETeval Visual Electrodiagnostic Device
Applicant
Lkc Technologies, Inc.
2 Professional Dr., Suite 222
Gaithersburg,  MD  20879
Applicant Contact Quentin Davis
Correspondent
Regulatory Affairs Associates, Inc.
40701 Woodward Ave., Suite 102
Bloomfield Hills,  MI  20879
Correspondent Contact Stephen J. Goldner
Regulation Number882.1890
Classification Product Code
GWE  
Date Received09/12/2014
Decision Date 05/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Clinical Trials NCT01950663
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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