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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 K911063
Device Name DAHLBERG MODEL LU BTE HEARING AID
Applicant
MIRACLE-EAR, INC.
600 SOUTH COUNTY RD. 18
MINNEAPOLIS,  MN  55426
Applicant Contact KEVIN L KUTINA
Correspondent
MIRACLE-EAR, INC.
600 SOUTH COUNTY RD. 18
MINNEAPOLIS,  MN  55426
Correspondent Contact KEVIN L KUTINA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received03/11/1991
Decision Date 03/21/1991
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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