TORAYSULFONE DIALYZER

Dialyzer, High Permeability With Or Without Sealed Dialysate System

TORAY INDUSTRIES (AMERICA), INC.

The following data is part of a premarket notification filed by Toray Industries (america), Inc. with the FDA for Toraysulfone Dialyzer.

Pre-market Notification Details

Device IDK002512
510k NumberK002512
Device Name:TORAYSULFONE DIALYZER
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant TORAY INDUSTRIES (AMERICA), INC. 540 COLLEGE ST. Bellaire,  TX  77401 -5010
ContactLisa S Jones
CorrespondentLisa S Jones
TORAY INDUSTRIES (AMERICA), INC. 540 COLLEGE ST. Bellaire,  TX  77401 -5010
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-15
Decision Date2001-10-15

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