HEMOCOR HPH MINI HEMOCONCENTRATOR

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 Hemocor Hph Mini Hemoconcentrator.

Pre-market Notification Details

Device IDK980859
510k NumberK980859
Device Name:HEMOCOR HPH MINI HEMOCONCENTRATOR
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
ContactMark Murphy
CorrespondentMark Murphy
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 Received1998-03-05
Decision Date1998-05-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30677964011116 K980859 000

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