ENEMA KIT 'Y' DESIGN— 510(k) K900847

Substantially Equivalent

Custom Medical Products, Ltd.

FDA 510(k) clearance K900847 for ENEMA KIT 'Y' DESIGN, Substantially Equivalent on 1990-04-13. Applicant: Custom Medical Products, Ltd..

Clearance details

Applicant: Custom Medical Products, Ltd.
Product code: Code FCE
Advisory panel: Gastroenterology, Urology
Date received: 1990-02-22
Decision date: 1990-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maineville, OH, US

Download summary PDF View on FDA.gov ↗

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.