SEARS MODEL 9098 ITE 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 Sears Model 9098 Ite Hearing Aid.

Pre-market Notification Details

Device IDK901351
510k NumberK901351
Device Name:SEARS MODEL 9098 ITE HEARING AID
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 Received1990-03-23
Decision Date1990-04-27

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