Name: [KDI] Dialyzer, High Permeability With Or Without Sealed Dialysate System — Class II (Special Controls)
Creator: FDA
Published: 2026-03-09T00:00:00+00:00
Keywords: code:KDI, class:2, regulation:876.5860, panel:GU, life_sustain:yes, 510k:K021615, 510k:K994267, 510k:K970446

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[KDI] Dialyzer, High Permeability With Or Without Sealed Dialysate System — Class II (S...

Mar 9, 2026

Captured: 2026-02-20Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDevice Class: 2

Specialty: Gastroenterology, Urology | Regulation: 21 CFR 876.5860 | Submission type: 1

•Agency: FDA
•Type: classification
•Source available

Panel:GU

Regulation Number:876.5860

Review Panel:GU

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