TELEX MODEL 28A ITE CUSTOM HEARING AID

Hearing Aid, Air Conduction

TELEX COMMUNICATIONS, INC.

The following data is part of a premarket notification filed by Telex Communications, Inc. with the FDA for Telex Model 28a Ite Custom Hearing Aid.

Pre-market Notification Details

Device IDK922066
510k NumberK922066
Device Name:TELEX MODEL 28A ITE CUSTOM HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis,  MN  55420
ContactHarry Teder
CorrespondentHarry Teder
TELEX COMMUNICATIONS, INC. 9600 ALDRICH AVENUE SOUTH Minneapolis,  MN  55420
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-04
Decision Date1992-05-18

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