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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 K063338
Device Name HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS 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 Received11/06/2006
Decision Date 01/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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