DAHLBERG MODEL LG BTE HEARING AID

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 Lg Bte Hearing Aid.

Pre-market Notification Details

Device IDK911064
510k NumberK911064
Device Name:DAHLBERG MODEL LG BTE HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis,  MN  55426
ContactKevin L Kutina
CorrespondentKevin L Kutina
MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis,  MN  55426
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-11
Decision Date1991-03-21

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