FDA 510(k) Application Details - K251845

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K251845
Device Name	Dressing, Wound, Collagen
Applicant	Kerecis Limited Sundastraeti 38, 400 Isafjordur P.O. Box 151, 400 Isafjordur Isafjordur 400 IS Other 510(k) Applications for this Company
Contact	Skuli Magnusson 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	06/16/2025
Decision Date	07/16/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review