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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K901556
Device Name AUDIOTONE MODEL FFI ITE HEARING AID
Applicant
Miracle-Ear, Inc.
600 S. County Rd. 18
Minneapolis,  MN  55426
Applicant Contact KEVIN KUTINA
Correspondent
Miracle-Ear, Inc.
600 S. County Rd. 18
Minneapolis,  MN  55426
Correspondent Contact KEVIN KUTINA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/03/1990
Decision Date 04/18/1990
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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