FDA 510(k) Application Details - DEN190042

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190042
Device Name	Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
Applicant	Baxter Healthcare Corporation 32650 North Wilson Road Round Lake, IL 60073 US Other 510(k) Applications for this Company
Contact	Kristen Bozzelli Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2019
Decision Date	08/28/2020
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review