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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, bone conduction
510(k) Number K062404
Device Name TRANSEAR BONE CONDUCTION HEARING AID
Applicant
EAR TECHNOLOGY CORP.
106 E WATAUGA AVE.
JOHNSON CITY,  TN  37601
Applicant Contact RICK GILBERT
Correspondent
EAR TECHNOLOGY CORP.
106 E WATAUGA AVE.
JOHNSON CITY,  TN  37601
Correspondent Contact RICK GILBERT
Regulation Number874.3302
Classification Product Code
LXB  
Date Received08/17/2006
Decision Date 09/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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