HEMOFILTRATION SYSTEM

Dialyzer, High Permeability With Or Without Sealed Dialysate System

GAMBRO, INC.

The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Hemofiltration System.

Pre-market Notification Details

Device IDK831784
510k NumberK831784
Device Name:HEMOFILTRATION SYSTEM
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-06-02
Decision Date1984-02-04

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