FACEPLATE ITE HEARING AID MODEL TCA

Face Plate Hearing Aid

TELEX COMMUNICATIONS, INC.

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

Pre-market Notification Details

Device IDK910900
510k NumberK910900
Device Name:FACEPLATE ITE HEARING AID MODEL TCA
ClassificationFace Plate Hearing Aid
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 CodeLRB  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-05
Decision Date1991-05-30

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