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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 K073384
Device Name SMART COUPLER, MODEL M015401
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  
Date Received12/03/2007
Decision Date 02/28/2008
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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