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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
510(k) Number K870079
Device Name MICRO-EAR CANAL IN-THE-EAR HEARING AID
Original Applicant
MICRO-EAR HEARING CENTER, INC.
4933 france avenue so.
minneapolis,  MN  55410
Original Contact hagen, m.a.
Regulation Number874.3300
Classification Product Code
ESD  
Date Received01/08/1987
Decision Date 03/03/1987
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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