Citric Complete Dry Citric Acid (45X)— 510(k) K171750

Substantially Equivalent

Dimesol USA, LLC

FDA 510(k) clearance K171750 for Citric Complete Dry Citric Acid (45X), Substantially Equivalent on 2018-03-06. Applicant: Dimesol USA, LLC.

Clearance details

Applicant: Dimesol USA, LLC
Product code: Code KPO
Advisory panel: Gastroenterology, Urology
Date received: 2017-06-13
Decision date: 2018-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lewisberry, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPO

product code KPO

Death: 14
Malfunction: 775
Other: 20
Total: 809

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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