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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 K123624
Device Name OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM
Applicant
MIMOSA ACOUSTICS, INC.
335 N Fremont St
CHAMPAIGN,  IL  61820
Applicant Contact PATRICIA S JENG
Correspondent
MIMOSA ACOUSTICS, INC.
335 N Fremont St
CHAMPAIGN,  IL  61820
Correspondent Contact PATRICIA S JENG
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
ETY  
Date Received11/23/2012
Decision Date 03/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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