FDA 510(k) Application Details - K243359

Device Classification Name	More FDA Info for this Device
510(K) Number	K243359
Device Name	MagDI System (MAG-02, DS-01)
Applicant	GT Metabolic Solutions, Inc. 3050 Three Springs Court San Jose, CA 95140 US Other 510(k) Applications for this Company
Contact	Lisa Griffin Vincent Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SAH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/2024
Decision Date	02/28/2025
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