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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 K934940
Device Name MIRACLE-EAR ENTRE
Applicant
MIRACLE-EAR, INC.
4101 DAHLBERG DR.
GOLDEN VALLEY,  MN  55422
Applicant Contact PAUL D'AMICO
Correspondent
MIRACLE-EAR, INC.
4101 DAHLBERG DR.
GOLDEN VALLEY,  MN  55422
Correspondent Contact PAUL D'AMICO
Regulation Number874.3300
Classification Product Code
ESD  
Date Received10/18/1993
Decision Date 03/07/1994
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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