Isopure Dry Acid Dissolution System

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

Isopure, Corp.

The following data is part of a premarket notification filed by Isopure, Corp. with the FDA for Isopure Dry Acid Dissolution System.

Pre-market Notification Details

Device IDK191093
510k NumberK191093
Device Name:Isopure Dry Acid Dissolution System
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant Isopure, Corp. 11851 Plantside Drive Louisville,  KY  40299
ContactKevin Gillespie
CorrespondentKevin Gillespie
Isopure, Corp. 11851 Plantside Drive Louisville,  KY  40299
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-25
Decision Date2020-01-22
Summary:summary

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.