FDA 510(k) Application Details - K251567

Device Classification Name	More FDA Info for this Device
510(K) Number	K251567
Device Name	NovoSorb BTM
Applicant	PolyNovo Biomaterials Pty Ltd 2/320 Lorimer Street Port Melbourne Melbourne 3207 AU Other 510(k) Applications for this Company
Contact	Shruti Dave 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	05/22/2025
Decision Date	06/20/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review