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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Auditory, Evoked Response
510(k) Number K061443
Device Name SMART USBLITE, MODEL M011120
Applicant
Intelligent Hearing Systems
6860 SW 81st St.
Miami,  FL  33143
Applicant Contact EDWARD MISKIEL
Correspondent
Intelligent Hearing Systems
6860 SW 81st St.
Miami,  FL  33143
Correspondent Contact EDWARD MISKIEL
Regulation Number882.1900
Classification Product Code
GWJ  
Subsequent Product Codes
EWO   GWL  
Date Received05/24/2006
Decision Date 06/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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