HF JUNIOR HEMOFILTER

Dialyzer, High Permeability With Or Without Sealed Dialysate System

MINNTECH CORP.

The following data is part of a premarket notification filed by Minntech Corp. with the FDA for Hf Junior Hemofilter.

Pre-market Notification Details

Device IDK071298
510k NumberK071298
Device Name:HF JUNIOR HEMOFILTER
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
ContactLynn Lueders
CorrespondentLynn Lueders
MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-09
Decision Date2007-08-08
Summary:summary

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