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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 K053216
Device Name HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
Applicant
MIMOSA ACOUSTICS, INC.
60 HAZELWOOD DR., SUITE #209
CHAMPAIGN,  IL  61820
Applicant Contact PATRICIA S JENG
Correspondent
MIMOSA ACOUSTICS, INC.
60 HAZELWOOD DR., SUITE #209
CHAMPAIGN,  IL  61820
Correspondent Contact PATRICIA S JENG
Regulation Number874.1050
Classification Product Code
EWO  
Subsequent Product Code
GWJ  
Date Received11/17/2005
Decision Date 02/10/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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