Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

Fresenius Medical Care Renal Therapies Group, LLC

The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate.

Pre-market Notification Details

Device IDK192209
510k NumberK192209
Device Name:Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
ContactDenise Oppermann
CorrespondentDenise Oppermann
Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham,  MA  02451
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-14
Decision Date2020-05-08

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