TORAY FILTRYZER DIALYZERS

Dialyzer, Capillary, Hollow Fiber

TORAY INDUSTRIES (AMERICA), INC.

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

Pre-market Notification Details

Device IDK884339
510k NumberK884339
Device Name:TORAY FILTRYZER DIALYZERS
ClassificationDialyzer, Capillary, Hollow Fiber
Applicant TORAY INDUSTRIES (AMERICA), INC. 280 PARK AVE. New York,  NY  10017
ContactKohki Ueno
CorrespondentKohki Ueno
TORAY INDUSTRIES (AMERICA), INC. 280 PARK AVE. New York,  NY  10017
Product CodeFJI  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-14
Decision Date1989-03-17

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