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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 K881737
Device Name AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AID
Applicant
AUDIOTONE, INC.
P.O. BOX 2905
PHOENIX,  AZ  85062
Applicant Contact JAMES A NUNLEY
Correspondent
AUDIOTONE, INC.
P.O. BOX 2905
PHOENIX,  AZ  85062
Correspondent Contact JAMES A NUNLEY
Regulation Number874.3300
Classification Product Code
ESD  
Date Received04/22/1988
Decision Date 05/13/1988
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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