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510(k) K160558

RAPIDO HOLLOW-FIBRE DIALYZERS by Bellco Srl — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2016
Date Received
February 29, 2016
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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  • K243505 — 5008X Hemodialysis System (May 30, 2025)
  • K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (May 15, 2025)
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