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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Audiometer
510(k) Number K011181
Device Name ICS MEDICAL CHARTR OAE WITH TYMP
Applicant
Ics Medical Corp.
125 Commerce Dr.
Schaumburg,  IL  60173 -5329
Applicant Contact DELMAR F BLOEM
Correspondent
Ics Medical Corp.
125 Commerce Dr.
Schaumburg,  IL  60173 -5329
Correspondent Contact DELMAR F BLOEM
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
ETY  
Date Received04/18/2001
Decision Date 06/25/2001
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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