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FDA 510(k) Application Details - K191457
Device Classification Name
More FDA Info for this Device
510(K) Number
K191457
Device Name
BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)
Applicant
MED-EL Elektromedizinische Geraete GmbH
Fuestenweg 77a
Innsbruck 6020 AT
Other 510(k) Applications for this Company
Contact
Ines Roman Santiago
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
05/31/2019
Decision Date
09/18/2019
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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