RENAL SYSTEMS HEMODIALYSIS CONCENTRATE

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 Renal Systems Hemodialysis Concentrate.

Pre-market Notification Details

Device IDK792213
510k NumberK792213
Device Name:RENAL SYSTEMS HEMODIALYSIS CONCENTRATE
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 Received1979-11-02
Decision Date1980-01-04

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