FB-U Hemodialyzer

Dialyzer, High Permeability With Or Without Sealed Dialysate System

NIPRO MEDICAL CORPORATION

The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Fb-u Hemodialyzer.

Pre-market Notification Details

Device IDK160444
510k NumberK160444
Device Name:FB-U Hemodialyzer
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant NIPRO MEDICAL CORPORATION 3150 NW 107TH AVE. Doral,  FL  33172
ContactJessica Oswald-mcleod
CorrespondentJessica Oswald-mcleod
NIPRO MEDICAL CORPORATION 3150 NW 107TH AVE. Doral,  FL  33172
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-17
Decision Date2017-02-08
Summary:summary

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