FDA 510(k) Application Details - K211943

Device Classification Name	Dressing, Wound, Drug   More FDA Info for this Device
510(K) Number	K211943
Device Name	Dressing, Wound, Drug
Applicant	Imbed Biosciences 5520 Nobel Drive, Suite 100 Madison, WI 53711 US Other 510(k) Applications for this Company
Contact	Ankit Agarwal 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	06/23/2021
Decision Date	10/17/2024
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