COLON IRRIGATION UNIT— 510(k) K840613

Substantially Equivalent

Colenz Co.

FDA 510(k) clearance K840613 for COLON IRRIGATION UNIT, Substantially Equivalent on 1984-07-17. Applicant: Colenz Co.. Device class: 2.

Clearance details

Applicant: Colenz Co.
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 1984-02-13
Decision date: 1984-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.