CLIRANS TE10 HOLLOW FIBER DIALYZER

Dialyzer, Capillary, Hollow Fiber

TERUMO AMERICA, INC.

The following data is part of a premarket notification filed by Terumo America, Inc. with the FDA for Clirans Te10 Hollow Fiber Dialyzer.

Pre-market Notification Details

Device IDK801192
510k NumberK801192
Device Name:CLIRANS TE10 HOLLOW FIBER DIALYZER
ClassificationDialyzer, Capillary, Hollow Fiber
Applicant TERUMO AMERICA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFJI  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-05-19
Decision Date1980-08-12

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