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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, Tactile
510(k) Number K831501
Device Name TACTIL EAR
Applicant
Ear Three Systems
MD 
Correspondent
Ear Three Systems
MD 
Classification Product Code
LRA  
Date Received05/11/1983
Decision Date 08/26/1983
Decision Substantially Equivalent (SESE)
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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