FDA 510(k) Application Details - K153364

Device Classification Name	More FDA Info for this Device
510(K) Number	K153364
Device Name	Kerecis SecureMesh
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	More FDA Info for this Regulation Number
Classification Product Code	OXE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2015
Decision Date	08/19/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review