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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 K030907
Device Name STACKED ABR FOR NAVIGATOR PRO
Applicant
Bio-Logic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Applicant Contact NORMAN E BRUNNER
Correspondent
Bio-Logic Systems Corp.
One Bio-Logic Plz.
Mudelein,  IL  60060
Correspondent Contact NORMAN E BRUNNER
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received03/24/2003
Decision Date 05/09/2003
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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