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510(k) K193542

Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 by Bellco Srl — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2020
Date Received
December 20, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

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