HEMODIALYSIS CONCENTRATE, SODIU

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

RENAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Hemodialysis Concentrate, Sodiu.

Pre-market Notification Details

Device IDK781967
510k NumberK781967
Device Name:HEMODIALYSIS CONCENTRATE, SODIU
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant RENAL SYSTEMS, 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 Received1978-11-24
Decision Date1978-12-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.