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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 K971399
Device Name AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
Applicant
General Hearing Instruments, Inc.
175 Brookhollow Espl.
Harahan,  LA  70123
Applicant Contact ROGER P JUNEAU
Correspondent
General Hearing Instruments, Inc.
175 Brookhollow Espl.
Harahan,  LA  70123
Correspondent Contact ROGER P JUNEAU
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/15/1997
Decision Date 06/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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