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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 K870079
Device Name MICRO-EAR CANAL IN-THE-EAR HEARING AID
Applicant
MICRO-EAR HEARING CENTER, INC.
4933 FRANCE AVENUE SO.
MINNEAPOLIS,  MN  55410
Applicant Contact HAGEN, M.A.
Correspondent
MICRO-EAR HEARING CENTER, INC.
4933 FRANCE AVENUE SO.
MINNEAPOLIS,  MN  55410
Correspondent Contact HAGEN, M.A.
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/08/1987
Decision Date 03/03/1987
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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