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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tester, Auditory Impedance
510(k) Number K854043
Device Name AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B
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 Number874.1090
Classification Product Code
ETY  
Date Received10/02/1985
Decision Date 12/31/1985
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
Predetermined Change
Control Plan Authorized		 No
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