TCA 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 Tca Hearing Aid.

Pre-market Notification Details

Device IDK843067
510k NumberK843067
Device Name:TCA HEARING AID
ClassificationHearing Aid, Air Conduction
Applicant TELEX COMMUNICATIONS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-08-06
Decision Date1984-09-05

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