CUSTODIOL HTK SOLUTION— 510(k) K020924

Name: FDA 510(k) clearance K020924
Creator: U.S. Food and Drug Administration
Published: 2003-01-06

Substantially Equivalent

Dr. Franz Kohler Chemie GmbH

FDA 510(k) clearance K020924 for CUSTODIOL HTK SOLUTION, Substantially Equivalent on 2003-01-06. Applicant: Dr. Franz Kohler Chemie GmbH. Device class: 2.

Clearance details

Applicant: Dr. Franz Kohler Chemie GmbH
Product code: Code KDL
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2002-03-21
Decision date: 2003-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brookeville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KDL

view all

K241239 — OrganProtex HTK Solution2025-01-24
K221386 — PERF-GEN Pulsatile Perfusion Solution2022-06-14
K221387 — BEL-GEN Cold Storage Solution2022-06-14
K211842 — Servator M SALF Solution2021-12-20
K192408 — Custodiol HTK Solution2020-04-24

More clearances from Dr. Franz Kohler Chemie GmbH

view all

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