RENAPAK CONCENTRATE MIXING SYS.

System, Dialysate Delivery, Central Multiple Patient

RENAL SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK840182
510k NumberK840182
Device Name:RENAPAK CONCENTRATE MIXING SYS.
ClassificationSystem, Dialysate Delivery, Central Multiple Patient
Applicant RENAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFKQ  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-01-17
Decision Date1984-05-02

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