CLIRANS TE08 HOLLOW FIBER DIALYZER— 510(k) K823768

Name: FDA 510(k) clearance K823768
Creator: U.S. Food and Drug Administration
Published: 1983-01-08

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K823768 for CLIRANS TE08 HOLLOW FIBER DIALYZER, Substantially Equivalent on 1983-01-08. Applicant: Terumo Medical Corp.. Device class: 2.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code HRN
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Date received: 1982-12-14
Decision date: 1983-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.