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FDA 510(k) Application Details - K100360
Device Classification Name
Hearing Aid, Bone Conduction
More FDA Info for this Device
510(K) Number
K100360
Device Name
Hearing Aid, Bone Conduction
Applicant
COCHLEAR AMERICAS
13059 E PEAKVIEW AVE
CENTENNIAL, CO 80111 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
LXB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/12/2010
Decision Date
07/13/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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