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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 K881652
Device Name AUDIOTONE MODEL A-61 BEHIND-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 Received04/15/1988
Decision Date 05/11/1988
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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