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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 K100360
Device Name BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT
Applicant
COCHLEAR AMERICAS
13059 E PEAKVIEW AVE
CENTENNIAL,  CO  80111
Applicant Contact SEAN BUNDY
Correspondent
COCHLEAR AMERICAS
13059 E PEAKVIEW AVE
CENTENNIAL,  CO  80111
Correspondent Contact SEAN BUNDY
Regulation Number874.3302
Classification Product Code
LXB  
Date Received02/12/2010
Decision Date 07/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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