FDA 510(k) Application Details - K211676

Device Classification Name	Expander, Skin, Inflatable   More FDA Info for this Device
510(K) Number	K211676
Device Name	Expander, Skin, Inflatable
Applicant	Motiva USA LLC 2543 Mesa School Lane Santa Barbara, CA 93109 US Other 510(k) Applications for this Company
Contact	Roslyn d'Incelli 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	06/01/2021
Decision Date	10/13/2023
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