MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300

Dialyzer, High Permeability With Or Without Sealed Dialysate System

MEDICA S.R.L.

The following data is part of a premarket notification filed by Medica S.r.l. with the FDA for Medica Hp 300 Hemofiltration Pump, Model 300.

Pre-market Notification Details

Device IDK000724
510k NumberK000724
Device Name:MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant MEDICA S.R.L. 100 MAIN ST. SUITE 120 Concord,  MA  01742
ContactJames Delaney
CorrespondentJames Delaney
MEDICA S.R.L. 100 MAIN ST. SUITE 120 Concord,  MA  01742
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-06
Decision Date2001-03-22

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