FDA 510(k) Application Details - K241904

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K241904
Device Name	Dressing, Wound, Collagen
Applicant	FesariusTherapeutics Inc. 760 Parkside Avenue, Suite 218 Brooklyn, NY 11226 US Other 510(k) Applications for this Company
Contact	Yulia Sapir-Lekhovitser Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	KGN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2024
Decision Date	01/06/2025
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