FDA 510(k) Application Details - K250746

Device Classification Name	More FDA Info for this Device
510(K) Number	K250746
Device Name	Magnetic Surgical System
Applicant	Levita Magnetics International Corp. 453 Ravendale Drive Mountain View, CA 94063 US Other 510(k) Applications for this Company
Contact	Donielle Baudin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/2025
Decision Date	06/07/2025
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