NATURALYTE BICARBONATE DIALYSATE CONCEN.

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

ERIKA, INC.

The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Naturalyte Bicarbonate Dialysate Concen..

Pre-market Notification Details

Device IDK810925
510k NumberK810925
Device Name:NATURALYTE BICARBONATE DIALYSATE CONCEN.
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant ERIKA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-06
Decision Date1981-04-23

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