A-22 HEMODIALYZER

Dialyzer, High Permeability With Or Without Sealed Dialysate System

ALTHIN MEDICAL AB

The following data is part of a premarket notification filed by Althin Medical Ab with the FDA for A-22 Hemodialyzer.

Pre-market Notification Details

Device IDK992563
510k NumberK992563
Device Name:A-22 HEMODIALYZER
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant ALTHIN MEDICAL AB FRIDHEMSVAGEN 15 Ronneby,  SE S-37221
ContactLars-olof Sandberb
CorrespondentLars-olof Sandberb
ALTHIN MEDICAL AB FRIDHEMSVAGEN 15 Ronneby,  SE S-37221
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-02
Decision Date2000-01-18
Summary:summary

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