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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
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