Colonic Plus Regular, Small, and Straight Shape Hydrokit— 510(k) K180800

Name: FDA 510(k) clearance K180800
Creator: U.S. Food and Drug Administration
Published: 2018-06-01

Unknown

Colonic Plus

FDA 510(k) clearance K180800 for Colonic Plus Regular, Small, and Straight Shape Hydrokit, Unknown on 2018-06-01. Applicant: Colonic Plus. Device class: 2.

Clearance details

Applicant: Colonic Plus
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 2018-03-27
Decision date: 2018-06-01
Decision: Unknown
Clearance type: Traditional
Location: Palm Desert, CA, US

Download summary PDF View on FDA.gov ↗

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