HD-SECURA HEMADIALYSIS MACHINE— 510(k) K854367

Name: FDA 510(k) clearance K854367
Creator: U.S. Food and Drug Administration
Published: 1985-12-16

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K854367 for HD-SECURA HEMADIALYSIS MACHINE, Substantially Equivalent on 1985-12-16. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code FKP
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-10-29
Decision date: 1985-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, 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.