HEMOCOR HPH 700 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 700 Hemoconcentrator.

Pre-market Notification Details

Device IDK983085
510k NumberK983085
Device Name:HEMOCOR HPH 700 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 Received1998-09-03
Decision Date1998-11-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30677964011185 K983085 000
30677964011178 K983085 000

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