FDA 510(k) Application Details - K203193

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K203193
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Bard Access Systems, Inc(BAS)[Wholly-owned subsidiary of BD] 605 North 5600 West Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Connor Dahl Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2020
Decision Date	03/04/2021
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