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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 K874510
Device Name RIONET HEARING AID HB-75
Applicant
RION ACOUSTIC INSTRUMENTS, INC.
912 W. 223RD ST.
TORRANCE,  CA  90502
Applicant Contact KIYOSHI ISHIYAMA
Correspondent
RION ACOUSTIC INSTRUMENTS, INC.
912 W. 223RD ST.
TORRANCE,  CA  90502
Correspondent Contact KIYOSHI ISHIYAMA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/02/1987
Decision Date 02/23/1988
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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