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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 K853638
Device Name RIONET HEARING AID
Applicant
RION ACOUSTIC INSTRUMENTS, INC.
555 SOUTH FLOWER ST.
26TH. FLOOR
LOS ANGELES,  CA  90017
Applicant Contact RICHARD G WALLACE
Correspondent
RION ACOUSTIC INSTRUMENTS, INC.
555 SOUTH FLOWER ST.
26TH. FLOOR
LOS ANGELES,  CA  90017
Correspondent Contact RICHARD G WALLACE
Regulation Number874.3300
Classification Product Code
ESD  
Date Received08/30/1985
Decision Date 09/23/1985
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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