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FDA 510(k) Application Details - DEN230084
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN230084
Device Name
Dexter L6 System
Applicant
Distalmotion, SA
Route de la Corniche 3B
Epalinges 1066 CH
Other 510(k) Applications for this Company
Contact
Larry Carrier
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
SDD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2023
Decision Date
10/25/2024
Decision
DENG -
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
FDA Source Information for DEN230084
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