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510(k) K252181

AquaA by Fresenius Medical Care North America — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2025
Date Received
July 11, 2025
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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