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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 K915319
Device Name RIONET HEARING AID HB-52AS
Applicant
Rion Co. Ltd. Dba Rion Acoustic Device
C/O Authorized Hearing Systems
806 Beaver St.
Bristol,  PA  19007
Applicant Contact EILEEN ANDERSON
Correspondent
Rion Co. Ltd. Dba Rion Acoustic Device
C/O Authorized Hearing Systems
806 Beaver St.
Bristol,  PA  19007
Correspondent Contact EILEEN ANDERSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received11/22/1991
Decision Date 01/09/1992
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
Predetermined Change
Control Plan Authorized		 No
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