FDA 510(k) Application Details - K153632

Device Classification Name	Mesh, Surgical, Polymeric   More FDA Info for this Device
510(K) Number	K153632
Device Name	Mesh, Surgical, Polymeric
Applicant	Aroa Biosurgery Limited (Formerly Mesynthes Limited) 2 Kingsford Smith Place, Airport Oaks Auckland 2022 NZ Other 510(k) Applications for this Company
Contact	Yasmin Rai Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	FTL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2015
Decision Date	06/16/2016
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