FDA 510(k) Application Details - K202430

Device Classification Name	More FDA Info for this Device
510(K) Number	K202430
Device Name	Kerecis Reconstruct
Applicant	Kerecis Limited Eyrargata 2 û PO Box 151 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	OXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2020
Decision Date	05/02/2021
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