K222734

Substantially Equivalent

Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing

Applicant: Diversatek Healthcare
Product code: OCX
Advisory panel: Gastroenterology, Urology
Date received: 2022-09-09
Decision date: 2022-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.