MODIFIED 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 Modified Toray Filtryzer Dialyzers.

Pre-market Notification Details

Device IDK882158
510k NumberK882158
Device Name:MODIFIED 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 Received1988-05-23
Decision Date1988-08-12

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