ADMINISTRATION SET, ENEMA— 510(k) K790005

Name: FDA 510(k) clearance K790005
Creator: U.S. Food and Drug Administration
Published: 1979-01-17

Substantially Equivalent

Kelsar Corp.

FDA 510(k) clearance K790005 for ADMINISTRATION SET, ENEMA, Substantially Equivalent on 1979-01-17. Applicant: Kelsar Corp.. Device class: 1.

Clearance details

Applicant: Kelsar Corp.
Product code: Code FCE
Device class: Class 1
Regulation: 21 CFR 876.5210
Advisory panel: Gastroenterology, Urology
Date received: 1979-01-02
Decision date: 1979-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K781987 — URINARY DRAINAGE BAG1978-12-04

Adverse events under product code FCE

product code FCE

Other: 2
Total: 2

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.