FDA 510(k) Application Details - K221686

Device Classification Name	More FDA Info for this Device
510(K) Number	K221686
Device Name	NovoSorb Matrix
Applicant	PolyNovo Biomaterials Pty Ltd 2/320 Lorimer St Port Melbourne 3207 AU Other 510(k) Applications for this Company
Contact	Tarun Nekkenti Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2022
Decision Date	09/15/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review