FDA 510(k) Application Details - K200502

Device Classification Name	Dressing, Wound, Collagen   More FDA Info for this Device
510(K) Number	K200502
Device Name	Dressing, Wound, Collagen
Applicant	Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks 2022 NZ Other 510(k) Applications for this Company
Contact	Tina O'Brien 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	02/28/2020
Decision Date	03/31/2021
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