HOLLOW FIBER DIALYZER HOLDER— 510(k) K802075

Name: FDA 510(k) clearance K802075
Creator: U.S. Food and Drug Administration
Published: 1980-09-16

Substantially Equivalent

Renal Devices, Inc.

FDA 510(k) clearance K802075 for HOLLOW FIBER DIALYZER HOLDER, Substantially Equivalent on 1980-09-16. Applicant: Renal Devices, Inc.. Device class: 2.

Clearance details

Applicant: Renal Devices, Inc.
Product code: Code FKI
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1980-08-27
Decision date: 1980-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FKI

view all

K843504 — AMER. BENTLEY HEMOFILTER HOLDER HFH-11984-10-18
K811292 — PARALLEL PLATE DIALYZER HOLDER1981-06-02

More clearances from Renal Devices, Inc.

view all

K810612 — HEMOPHRON1981-04-29
K801559 — HOLLO FIBER DIALYZER1980-10-31
K790696 — RDI-1 HOLLOW FIBER DIALYZER1979-06-20

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