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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 K960097
Device Name CHARTR EP
Applicant
ICS MEDICAL CORP.
2227 HAMMOND DR.
SCHAUMBURG,  IL  60173 -3860
Applicant Contact DELMAR F BLOEM
Correspondent
ICS MEDICAL CORP.
2227 HAMMOND DR.
SCHAUMBURG,  IL  60173 -3860
Correspondent Contact DELMAR F BLOEM
Regulation Number882.1900
Classification Product Code
GWJ  
Date Received01/11/1996
Decision Date 02/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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