GENTLE COLONICS IRRIGATION SYSTEM— 510(k) K002102

Name: FDA 510(k) clearance K002102
Creator: U.S. Food and Drug Administration
Published: 2002-02-06

Substantially Equivalent

Gentle Colonics, Inc.

FDA 510(k) clearance K002102 for GENTLE COLONICS IRRIGATION SYSTEM, Substantially Equivalent on 2002-02-06. Applicant: Gentle Colonics, Inc.. Device class: 2.

Clearance details

Applicant: Gentle Colonics, Inc.
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 2000-07-12
Decision date: 2002-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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