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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 K904926
Device Name SMART-EP
Applicant
Intelligent Hearing Systems
1125 NE 125 St., Suite
206
North Miami,  FL  33161
Applicant Contact EDWARD MISKIEL
Correspondent
Intelligent Hearing Systems
1125 NE 125 St., Suite
206
North Miami,  FL  33161
Correspondent Contact EDWARD MISKIEL
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received10/31/1990
Decision Date 08/02/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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