FDA 510(k) Application Details - K243213

Device Classification Name	More FDA Info for this Device
510(K) Number	K243213
Device Name	Self-Forming Magnet (FLEX SFM)
Applicant	GI Windows Inc. 380 University Ave. Westwood, MA 02090 US Other 510(k) Applications for this Company
Contact	Yverre Bobay 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	10/03/2024
Decision Date	01/29/2025
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