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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 K873468
Device Name CUSTOM IN-THE-EAR HEARING AID SERIES MCA20
Applicant
MAICO HEARING INSTRUMENTS, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2029
Applicant Contact DUANE SMEDSRUD
Correspondent
MAICO HEARING INSTRUMENTS, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2029
Correspondent Contact DUANE SMEDSRUD
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/28/1987
Decision Date 09/29/1987
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
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