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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 K941140
Device Name RIONET HEARING AID HB-37T
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 Received03/10/1994
Decision Date 05/04/1994
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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