BLOOD TUBING

Accessories, Blood Circuit, Hemodialysis

RENAL SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK834596
510k NumberK834596
Device Name:BLOOD TUBING
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant RENAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-12-30
Decision Date1984-02-04

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