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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 K090720
Device Name COCHLEAR BAHA BP100
Applicant
COCHLEAR BONE ANCHORED SYSTEMS AB
13059 E. PEAKVIEW AVE.
CENTENNIAL,  CO  80111
Applicant Contact SEAN BUNDY
Correspondent
COCHLEAR BONE ANCHORED SYSTEMS AB
13059 E. PEAKVIEW AVE.
CENTENNIAL,  CO  80111
Correspondent Contact SEAN BUNDY
Regulation Number874.3302
Classification Product Code
LXB  
Date Received03/18/2009
Decision Date 06/17/2009
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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