FDA 510(k) Application Details - K250435

Device Classification Name	More FDA Info for this Device
510(K) Number	K250435
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	More FDA Info for this Regulation Number
Classification Product Code	SDD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2025
Decision Date	05/27/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review