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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name hearing aid, air-conduction, prescription
510(k) Number K842875
Device Name RIONET HEARING AID HB-35
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 Number874.3300
Classification Product Code
ESD  
Date Received07/23/1984
Decision Date 08/24/1984
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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