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510(k) K211035

U9000 Plus Ultrafilter by Baxter Healthcare Corporation — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2021
Date Received
April 7, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type

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