CLIRANS TE08 HOLLOW FIBER DIALYZER

Unit, Cryophthalmic, Ac-powered

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Clirans Te08 Hollow Fiber Dialyzer.

Pre-market Notification Details

Device IDK823768
510k NumberK823768
Device Name:CLIRANS TE08 HOLLOW FIBER DIALYZER
ClassificationUnit, Cryophthalmic, Ac-powered
Applicant TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeHRN  
CFR Regulation Number886.4170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-14
Decision Date1983-01-08

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