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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 K862670
Device Name RIONET HEARING AID HB-35PT
Applicant
RION ACOUSTIC INSTRUMENTS, INC.
912 W. 223RD ST.
TORRANCE,  CA  90502
Applicant Contact MASATSUGU OTSUKA
Correspondent
RION ACOUSTIC INSTRUMENTS, INC.
912 W. 223RD ST.
TORRANCE,  CA  90502
Correspondent Contact MASATSUGU OTSUKA
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/14/1986
Decision Date 07/31/1986
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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