COLONIC AND ENEMA NOZZLE— 510(k) K051344

Name: FDA 510(k) clearance K051344
Creator: U.S. Food and Drug Administration
Published: 2005-08-18

Substantially Equivalent

Ultimate Concepts, Inc.

FDA 510(k) clearance K051344 for COLONIC AND ENEMA NOZZLE, Substantially Equivalent on 2005-08-18. Applicant: Ultimate Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Ultimate Concepts, Inc.
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 2005-05-23
Decision date: 2005-08-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, 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.