FDA 510(k) Application Details - K190528

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K190528
Device Name	Dressing, Wound, Collagen
Applicant	Kerecis Limited Eyrargata 2 Isafjordur 400 IS Other 510(k) Applications for this Company
Contact	Gudmundur Fertram Sigurjonsson 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	03/04/2019
Decision Date	07/10/2019
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