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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Audiometer Calibration
510(k) Number K780474
Device Name AUDIOMETER CALIBRATOR MODEL RA 310
Applicant
TRACOR INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
TRACOR INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.1080
Classification Product Code
EWA  
Date Received03/24/1978
Decision Date 03/30/1978
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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