RENATRON DIALYZER REPROCESSING SYS

Dialyzer Reprocessing System

RENAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Renatron Dialyzer Reprocessing Sys.

Pre-market Notification Details

Device IDK830574
510k NumberK830574
Device Name:RENATRON DIALYZER REPROCESSING SYS
ClassificationDialyzer Reprocessing System
Applicant RENAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLIF  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-23
Decision Date1983-03-29

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