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FDA 510(k) Application Details - K200504
Device Classification Name
More FDA Info for this Device
510(K) Number
K200504
Device Name
BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote
Applicant
MED-EL Elektromedizinische Geraete GmbH
Fuerstenweg 77a
Innsbruck 6020 AT
Other 510(k) Applications for this Company
Contact
Carolin Ralser
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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
03/02/2020
Decision Date
07/29/2020
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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