ELISIO-H 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 Elisio-h Hemodialyzer.

Pre-market Notification Details

Device IDK140191
510k NumberK140191
Device Name:ELISIO-H HEMODIALYZER
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant NIPRO MEDICAL CORPORATION 3150 NW 107 AVE., Miami,  FL  33172
ContactCarolyn George
CorrespondentCarolyn George
NIPRO MEDICAL CORPORATION 3150 NW 107 AVE., Miami,  FL  33172
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-01-27
Decision Date2014-04-14
Summary:summary

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