Optiflux Enexa F500 Dialyzer

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Fresenius Medical Care Reanal Therapies Group LLC

The following data is part of a premarket notification filed by Fresenius Medical Care Reanal Therapies Group Llc with the FDA for Optiflux Enexa F500 Dialyzer.

Pre-market Notification Details

Device IDK192928
510k NumberK192928
Device Name:Optiflux Enexa F500 Dialyzer
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant Fresenius Medical Care Reanal Therapies Group LLC 920 Winter Street Waltham,  MA  02451
ContactDenise Oppermann
CorrespondentDenise Oppermann
Fresenius Medical Care Reanal Therapies Group LLC 920 Winter Street Waltham,  MA  02451
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-17
Decision Date2020-07-09

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