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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name hearing aid, air conduction
510(k) Number K791506
Device Name MODEL 344
Original Applicant
TELEX COMMUNICATIONS, INC.
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/03/1979
Decision Date 09/19/1979
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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