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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 K972344
Device Name MIRACLE-EAR DIGITAL BTE
Applicant
MIRACLE-EAR, INC.
4101 DAHLBERG DR.
GOLDEN VALLEY,  MN  55422
Applicant Contact MELANIE RASKA
Correspondent
MIRACLE-EAR, INC.
4101 DAHLBERG DR.
GOLDEN VALLEY,  MN  55422
Correspondent Contact MELANIE RASKA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/24/1997
Decision Date 07/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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