ASAHI NEW PAN-SERIES HEMOFILTERS

Dialyzer, High Permeability With Or Without Sealed Dialysate System

ASAHI MEDICAL CO., LTD.

The following data is part of a premarket notification filed by Asahi Medical Co., Ltd. with the FDA for Asahi New Pan-series Hemofilters.

Pre-market Notification Details

Device IDK844663
510k NumberK844663
Device Name:ASAHI NEW PAN-SERIES HEMOFILTERS
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant ASAHI MEDICAL CO., LTD. C/O ADVOCACY SERVICES GROUP 1825 I STREET, N.W., SUITE 400 Washington,  DC  20006
ContactRichard T Ney
CorrespondentRichard T Ney
ASAHI MEDICAL CO., LTD. C/O ADVOCACY SERVICES GROUP 1825 I STREET, N.W., SUITE 400 Washington,  DC  20006
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-30
Decision Date1985-01-18

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