FDA 510(k) Application Details - DEN230084

Device Classification Name

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510(K) Number DEN230084
Device Name Dexter L6 System
Applicant Distalmotion, SA
Route de la Corniche 3B
Epalinges 1066 CH
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Contact Larry Carrier
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Regulation Number

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Classification Product Code SDD
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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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