DOTOLO COLON HYDROTHERAPY INSTRUMENT— 510(k) K870534

Name: FDA 510(k) clearance K870534
Creator: U.S. Food and Drug Administration
Published: 1987-06-18

Substantially Equivalent

Dotolo Research Corp. C/O Keller and Heckman

FDA 510(k) clearance K870534 for DOTOLO COLON HYDROTHERAPY INSTRUMENT, Substantially Equivalent on 1987-06-18. Applicant: Dotolo Research Corp. C/O Keller and Heckman. Device class: 2.

Clearance details

Applicant: Dotolo Research Corp. C/O Keller and Heckman
Product code: Code KPL
Device class: Class 2
Regulation: 21 CFR 876.5220
Advisory panel: Gastroenterology, Urology
Date received: 1987-02-09
Decision date: 1987-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.