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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Face Plate Hearing Aid
510(k) Number K834479
Device Name RELIABLE
Applicant
Reliable Hearing Aide
MD 
Correspondent
Reliable Hearing Aide
MD 
Regulation Number874.3300
Classification Product Code
LRB  
Date Received12/20/1983
Decision Date 07/11/1984
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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