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FDA 510(k) Application Details - K080363
Device Classification Name
Hearing Aid, Bone Conduction, Implanted
More FDA Info for this Device
510(K) Number
K080363
Device Name
Hearing Aid, Bone Conduction, Implanted
Applicant
COCHLEAR BONE ANCHORED SYSTEMS AB
400 INVERNESS PARKWAY
SUITE 400
ENGLEWOOD, CO 80112 US
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Contact
SEAN BUNDY
Other 510(k) Applications for this Contact
Regulation Number
874.3300
More FDA Info for this Regulation Number
Classification Product Code
MAH
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More FDA Info for this Product Code
Date Received
02/11/2008
Decision Date
04/10/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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