FDA 510(k) Application Details - K183398

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K183398
Device Name	Mesh, Surgical
Applicant	Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks 2022 NZ Other 510(k) Applications for this Company
Contact	Tina OÆBrien Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2018
Decision Date	04/11/2019
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