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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 K963874
Device Name AHS OMEGA AGC
Applicant
AUTHORIZED HEARING SYSTEMS, INC.
806 BEAVER ST.
BRISTOL,  PA  19007
Applicant Contact HENRY SMITH
Correspondent
AUTHORIZED HEARING SYSTEMS, INC.
806 BEAVER ST.
BRISTOL,  PA  19007
Correspondent Contact HENRY SMITH
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/26/1996
Decision Date 11/26/1996
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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