FDA 510(k) Application Details - K241385

Device Classification Name	More FDA Info for this Device
510(K) Number	K241385
Device Name	Omnifix Syringe NRFit
Applicant	B. Braun Medical Inc. 824 Twelfth Avenue Bethlehem, PA 18018 US Other 510(k) Applications for this Company
Contact	Smith Kimberly Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2024
Decision Date	07/13/2024
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