HEMOCOR HP HEMOCONCENTRATOR SERIES

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 Hp Hemoconcentrator Series.

Pre-market Notification Details

Device IDK923139
510k NumberK923139
Device Name:HEMOCOR HP HEMOCONCENTRATOR SERIES
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
ContactLeroy J Fischbach
CorrespondentLeroy J Fischbach
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 Received1992-06-29
Decision Date1994-02-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30677964011253 K923139 000
00677964011245 K923139 000
30677964011239 K923139 000
30677964011222 K923139 000
00677964011214 K923139 000
30677964011208 K923139 000

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