FDA 510(k) Application Details - K250598

Device Classification Name	Mesh, Surgical   More FDA Info for this Device
510(K) Number	K250598
Device Name	Mesh, Surgical
Applicant	Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks Auckland 2022 NZ Other 510(k) Applications for this Company
Contact	Stacy Spies 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	02/28/2025
Decision Date	06/03/2025
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