FDA 510(k) Application Details - K192538

Device Classification Name	More FDA Info for this Device
510(K) Number	K192538
Device Name	BD Syringe NRFit Lok and BD Syringe NRFit Slip
Applicant	Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, NJ 07417 US Other 510(k) Applications for this Company
Contact	Murtaza Rana 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	09/16/2019
Decision Date	09/04/2020
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