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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name masker, tinnitus
510(k) Number K061459
Device Name TRANQUIL TRI-BTE
Applicant
GENERAL HEARING INSTRUMENTS, INC.
P.O. BOX 23748
NEW ORLEANS,  LA  70183 -0748
Applicant Contact ROGER P JUNEAU
Correspondent
GENERAL HEARING INSTRUMENTS, INC.
P.O. BOX 23748
NEW ORLEANS,  LA  70183 -0748
Correspondent Contact ROGER P JUNEAU
Regulation Number874.3400
Classification Product Code
KLW  
Date Received05/26/2006
Decision Date 06/30/2006
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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