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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 K790846
Device Name MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)
Original Applicant
GRASON-STADLER, INC.
Regulation Number874.1050
Classification Product Code
EWO  
Date Received05/04/1979
Decision Date 05/17/1979
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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