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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name audiometer
510(k) Number K844069
Device Name TA-201 CLINICAL AUDIOMETER
Applicant
TELEDYNE AVIONICS DIV. OF TELEDYNE
P.O. BOX 6400 (RT. 743)
CHARLOTTESVILLE,  VA  22906
Applicant Contact JACK COWARDIN
Correspondent
TELEDYNE AVIONICS DIV. OF TELEDYNE
P.O. BOX 6400 (RT. 743)
CHARLOTTESVILLE,  VA  22906
Correspondent Contact JACK COWARDIN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received10/18/1984
Decision Date 12/03/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
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