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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 K897035
Device Name MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
Applicant
MIRACLE-EAR, INC.
7731 COUNTRY CLUB DR.
GOLDEN VALLEY,  MN  55427
Applicant Contact KEVIN L KUTINA
Correspondent
MIRACLE-EAR, INC.
7731 COUNTRY CLUB DR.
GOLDEN VALLEY,  MN  55427
Correspondent Contact KEVIN L KUTINA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received12/18/1989
Decision Date 05/23/1990
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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