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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 K811509
Device Name AUTO-TYMPANIGRAPH (TA-5A)
Applicant
TELEDYNE AVIONICS DIV. OF TELEDYNE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TELEDYNE AVIONICS DIV. OF TELEDYNE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.1090
Classification Product Code
ETY  
Date Received05/27/1981
Decision Date 06/16/1981
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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