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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 K950637
Device Name MAICO IN-THE-EAR MODEL RD-312 CIC
Applicant
MAICO HEARING INSTRUMENTS, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2029
Applicant Contact MIKE CZURAS
Correspondent
MAICO HEARING INSTRUMENTS, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS,  MN  55439 -2029
Correspondent Contact MIKE CZURAS
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/13/1995
Decision Date 03/21/1995
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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