DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT

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 Dahlberg Model Jh In-the-ear Hearing Instrument.

Pre-market Notification Details

Device IDK900861
510k NumberK900861
Device Name:DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT
ClassificationHearing Aid, Air Conduction
Applicant MIRACLE-EAR, INC. 7731 COUNTRY CLUB DR. Golden Valley,  MN  55427
ContactKevin Kutina
CorrespondentKevin Kutina
MIRACLE-EAR, INC. 7731 COUNTRY CLUB DR. Golden Valley,  MN  55427
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-23
Decision Date1990-04-04

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