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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 K895517
Device Name AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC
Applicant
Aural Technologies, Inc.
310 E. Chestnut St.
Rome,  NY  13440
Applicant Contact ECUNG
Correspondent
Aural Technologies, Inc.
310 E. Chestnut St.
Rome,  NY  13440
Correspondent Contact ECUNG
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/12/1989
Decision Date 01/04/1990
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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