ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM— 510(k) K033149

Name: FDA 510(k) clearance K033149
Creator: U.S. Food and Drug Administration
Published: 2004-03-23

Substantially Equivalent

Ultimate Concepts, Inc.

FDA 510(k) clearance K033149 for ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM, Substantially Equivalent on 2004-03-23. 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: 2003-09-30
Decision date: 2004-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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