FDA 510(k) Application Details - K230951

Device Classification Name	More FDA Info for this Device
510(K) Number	K230951
Device Name	Terumo Injection Filter Needle (NF-3013RBKE05M)
Applicant	Terumo Europe N.V. Interleuvenlaan 40 Leuven 3012 BE Other 510(k) Applications for this Company
Contact	Liesbeth Decoster Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QYM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/04/2023
Decision Date	10/18/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review