FDA 510(k) Application Details - K180395

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K180395
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Arrow International, Inc. (Subsidiary of Teleflex, Inc.) 2400 Bernville Road Reading, PA 19605 US Other 510(k) Applications for this Company
Contact	Frank Pelc 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	02/13/2018
Decision Date	11/09/2018
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