MIRACLE-EAR MODEL PGC

Hearing Aid, Air Conduction

MIRACLE-EAR/DAHLBERG, INC.

The following data is part of a premarket notification filed by Miracle-ear/dahlberg, Inc. with the FDA for Miracle-ear Model Pgc.

Pre-market Notification Details

Device IDK942894
510k NumberK942894
Device Name:MIRACLE-EAR MODEL PGC
ClassificationHearing Aid, Air Conduction
Applicant MIRACLE-EAR/DAHLBERG, INC. 4101 DAHLBERG DR. Golden Valley,  MN  55422
ContactMelanie Raska
CorrespondentMelanie Raska
MIRACLE-EAR/DAHLBERG, INC. 4101 DAHLBERG DR. Golden Valley,  MN  55422
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-20
Decision Date1994-08-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.