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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 K920897
Device Name RIONET HEARING AID - HB 52DU
Applicant
AUTHORIZED HEARING SYSTEMS, INC.
806 BEAVER ST.
BRISTOL,  PA  19007
Applicant Contact EILEEN ANDERSON
Correspondent
AUTHORIZED HEARING SYSTEMS, INC.
806 BEAVER ST.
BRISTOL,  PA  19007
Correspondent Contact EILEEN ANDERSON
Regulation Number874.3300
Classification Product Code
ESD  
Date Received02/26/1992
Decision Date 03/19/1992
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
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