FDA 510(k) Application Details - K242963

Device Classification Name	Expander, Skin, Inflatable   More FDA Info for this Device
510(K) Number	K242963
Device Name	Expander, Skin, Inflatable
Applicant	Mentor Worldwide LLC 31 Technology Drive Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Alicia Botham Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2024
Decision Date	04/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review