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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 K100649
Device Name SOUNDBITE HEARING SYSTEM BY SONITUS
Applicant
Sonitus Medical, Inc.
25 Hartford Ave.
San Carlos,  CA  94070
Applicant Contact ROBERT J CHIN
Correspondent
Sonitus Medical, Inc.
25 Hartford Ave.
San Carlos,  CA  94070
Correspondent Contact ROBERT J CHIN
Regulation Number874.3302
Classification Product Code
LXB  
Date Received03/08/2010
Decision Date 01/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT00977314
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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