RENAFLO HOLLOW FIBER DIALYZER #100.1

Dialyzer, Capillary, Hollow Fiber

RENAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Renaflo Hollow Fiber Dialyzer #100.1.

Pre-market Notification Details

Device IDK801827
510k NumberK801827
Device Name:RENAFLO HOLLOW FIBER DIALYZER #100.1
ClassificationDialyzer, Capillary, Hollow Fiber
Applicant RENAL SYSTEMS, 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 Received1980-07-31
Decision Date1980-09-26

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