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FDA 510(k) Application Details - DEN170009
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN170009
Device Name
Bonebridge
Applicant
MED-EL Elektromedizinische Geraete GmbH
Fuerstenweg 77a
Innsbruck 6020 AT
Other 510(k) Applications for this Company
Contact
Elizabeth Gfoeller
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PFO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/13/2017
Decision Date
07/20/2018
Decision
DENG -
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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