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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 K891373
Device Name TRACOR RA500 AUDIOMETER
Applicant
Tracor Instruments Austin, Inc.
6500 Tracor Ln.
Austin,  TX  78725
Applicant Contact JACK C FOREMAN
Correspondent
Tracor Instruments Austin, Inc.
6500 Tracor Ln.
Austin,  TX  78725
Correspondent Contact JACK C FOREMAN
Regulation Number874.1050
Classification Product Code
EWO  
Date Received03/09/1989
Decision Date 07/14/1989
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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