REDOX CONTROLLER— 510(k) K830994

Name: FDA 510(k) clearance K830994
Creator: U.S. Food and Drug Administration
Published: 1983-05-27

Substantially Equivalent

St. Louis Univ. Medical Center

FDA 510(k) clearance K830994 for REDOX CONTROLLER, Substantially Equivalent on 1983-05-27. Applicant: St. Louis Univ. Medical Center. Device class: 2.

Clearance details

Applicant: St. Louis Univ. Medical Center
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 1983-03-29
Decision date: 1983-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.