MIRACLE EAR AND AUDIOTONE

Hearing Aid, Air Conduction

MIRACLE-EAR, INC.

The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Miracle Ear And Audiotone.

Pre-market Notification Details

Device IDK954941
510k NumberK954941
Device Name:MIRACLE EAR AND AUDIOTONE
ClassificationHearing Aid, Air Conduction
Applicant MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley,  MN  55422
ContactMelaniek Raska
CorrespondentMelaniek Raska
MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley,  MN  55422
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-10-30
Decision Date1995-12-22

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