HEMOPERFUSION PROCEDURE W/REDY 2000— 510(k) K842513

Name: FDA 510(k) clearance K842513
Creator: U.S. Food and Drug Administration
Published: 1984-09-12

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K842513 for HEMOPERFUSION PROCEDURE W/REDY 2000, Substantially Equivalent on 1984-09-12. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code FKT
Device class: Class 2
Regulation: 21 CFR 876.5600
Advisory panel: Gastroenterology, Urology
Date received: 1984-06-26
Decision date: 1984-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K043574 — ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 10002005-06-03

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