FDA 510(k) Application Details - K211649

Device Classification Name	More FDA Info for this Device
510(K) Number	K211649
Device Name	PCEA Syringe Set
Applicant	Baxter Healthcare Corporation 25212 West Illinois Route 120 Round Lake, IL 60073 US Other 510(k) Applications for this Company
Contact	Jeffrey E Thompson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2021
Decision Date	11/23/2021
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