FDA 510(k) Application Details - K241080

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K241080
Device Name	Dressing, Wound, Collagen
Applicant	Kerecis Limited Sundstraeti 38, 400 Isafjordur P.O. Box 151, 400 Isafjordur Isafjordur IS Other 510(k) Applications for this Company
Contact	William Kabitz 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	04/19/2024
Decision Date	08/21/2024
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