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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 K923801
Device Name RIONET HB75-AL BTE AID
Applicant
AUTHORIZED HEARING SYSTEMS, INC.
806 BEAVER ST.
BRISTOL,  PA  19007
Applicant Contact HENRY C SMITH
Correspondent
AUTHORIZED HEARING SYSTEMS, INC.
806 BEAVER ST.
BRISTOL,  PA  19007
Correspondent Contact HENRY C SMITH
Regulation Number874.3300
Classification Product Code
ESD  
Date Received07/29/1992
Decision Date 09/28/1992
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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