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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 K802207
Device Name RION DIAGNOSTIC AUDIOMETER
Applicant
RION ACOUSTIC INSTRUMENTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
RION ACOUSTIC INSTRUMENTS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number874.1050
Classification Product Code
EWO  
Date Received09/11/1980
Decision Date 09/26/1980
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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