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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 K860671
Device Name DAHLBERG MODEL EF BEHIND-THE-EAR HEARING AID
Applicant
Miracle-Ear/Dahlberg, Inc.
7731 Country Club Dr.
Golden Valley,  MN  55427
Applicant Contact ROBERT E MEYER
Correspondent
Miracle-Ear/Dahlberg, Inc.
7731 Country Club Dr.
Golden Valley,  MN  55427
Correspondent Contact ROBERT E MEYER
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/24/1986
Decision Date 04/03/1986
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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