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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K843226
Device Name EVOKED RESPONSE ELECTRICAL STIMULATOR
Applicant
Nucleus, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Nucleus, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number874.1820
Classification Product Code
ETN  
Date Received08/16/1984
Decision Date 05/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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