FDA 510(k) Application Details - K212554

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K212554
Device Name	Dressing, Wound, Drug
Applicant	StemCyte Inc. 13800 Live Oak Avenue Baldwin Park, CA 91706 US Other 510(k) Applications for this Company
Contact	Angel Hsieh Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	FRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/13/2021
Decision Date	08/19/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review