HOLLO FIBER DIALYZER

Dialyzer, Capillary, Hollow Fiber

RENAL DEVICES, INC.

The following data is part of a premarket notification filed by Renal Devices, Inc. with the FDA for Hollo Fiber Dialyzer.

Pre-market Notification Details

Device IDK801559
510k NumberK801559
Device Name:HOLLO FIBER DIALYZER
ClassificationDialyzer, Capillary, Hollow Fiber
Applicant RENAL DEVICES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFJI  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-07-08
Decision Date1980-10-31

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