FDA 510(k) Application Details - K201415

Device Classification Name	Set, I.V. Fluid Transfer   More FDA Info for this Device
510(K) Number	K201415
Device Name	Set, I.V. Fluid Transfer
Applicant	West Pharmaceutical Services AZ, Inc. 14677 North 74th Street Scottsdale, AZ 85260 US Other 510(k) Applications for this Company
Contact	Elena Mack Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	LHI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/2020
Decision Date	10/21/2020
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