FRESENIUS ULTRAFLUX AV400, AV600

Dialyzer, High Permeability With Or Without Sealed Dialysate System

SERATRONICS, INC.

The following data is part of a premarket notification filed by Seratronics, Inc. with the FDA for Fresenius Ultraflux Av400, Av600.

Pre-market Notification Details

Device IDK864587
510k NumberK864587
Device Name:FRESENIUS ULTRAFLUX AV400, AV600
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant SERATRONICS, INC. 4090 PIKE LN. Concord,  CA  94520
ContactScott N Walker
CorrespondentScott N Walker
SERATRONICS, INC. 4090 PIKE LN. Concord,  CA  94520
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-21
Decision Date1987-03-03

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