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510(k) K963440

DIALOG DIALYSIS MACHINE by B. Braun Medical AG — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1998
Date Received
August 30, 1996
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

Other clearances by B. Braun Medical AG

  • K962084 — OMNICAN SYRINGE (February 10, 1997)

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  • K242053 — FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (March 21, 2025)