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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 K913356
Device Name THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER
Applicant
MONITOR INSTRUMENTS, INC.
605 EASTOWNE DR.
CHAPEL HILL,  NC  27514
Applicant Contact MACK J PRESLAR
Correspondent
MONITOR INSTRUMENTS, INC.
605 EASTOWNE DR.
CHAPEL HILL,  NC  27514
Correspondent Contact MACK J PRESLAR
Regulation Number874.1050
Classification Product Code
EWO  
Date Received07/30/1991
Decision Date 12/05/1991
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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