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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 K050653
Device Name TRANSEAR BONE CONDUCTION HEARING AID
Applicant
UNITED HEARING SYSTEMS, INC.
137 NORWICH RD.
CENTRAL VILLAGE,  CT  06332
Applicant Contact RALPH CAMPAGNA
Correspondent
UNITED HEARING SYSTEMS, INC.
137 NORWICH RD.
CENTRAL VILLAGE,  CT  06332
Correspondent Contact RALPH CAMPAGNA
Regulation Number874.3302
Classification Product Code
LXB  
Date Received03/11/2005
Decision Date 07/01/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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