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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 K943144
Device Name AURIS CIC
Applicant
General Hearing Instruments, Inc.
P.O. Box 61010
New Orleans,  LA  70161
Applicant Contact ROGER P JUNEAU
Correspondent
General Hearing Instruments, Inc.
P.O. Box 61010
New Orleans,  LA  70161
Correspondent Contact ROGER P JUNEAU
Regulation Number874.3300
Classification Product Code
ESD  
Date Received06/29/1994
Decision Date 07/20/1994
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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