PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000

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 Primus Hollow Fiber Dialyzer Mod. 1000, 1350, 2000.

Pre-market Notification Details

Device IDK923727
510k NumberK923727
Device Name:PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant MINNTECH CORP. 14605 28TH AVE. NORTH Minneapolis,  MN  55447
ContactLeroy Fishbach
CorrespondentLeroy Fishbach
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 Received1992-07-27
Decision Date1994-07-29

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