ASAHI REXEED-SX/LX SERIES DIALYZER

Dialyzer, High Permeability With Or Without Sealed Dialysate System

ASAHI KASEI MEDICAL CO., LTD.

The following data is part of a premarket notification filed by Asahi Kasei Medical Co., Ltd. with the FDA for Asahi Rexeed-sx/lx Series Dialyzer.

Pre-market Notification Details

Device IDK121409
510k NumberK121409
Device Name:ASAHI REXEED-SX/LX SERIES DIALYZER
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant ASAHI KASEI MEDICAL CO., LTD. 154 MAIN STREET, STE 2 Charlestown,  NH  03603
ContactPatsy Trisler
CorrespondentPatsy Trisler
ASAHI KASEI MEDICAL CO., LTD. 154 MAIN STREET, STE 2 Charlestown,  NH  03603
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-11
Decision Date2013-02-06
Summary:summary

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