ENEMA SET— 510(k) K771792

Substantially Equivalent

Chase Mfg. Co.

FDA 510(k) clearance K771792 for ENEMA SET, Substantially Equivalent on 1977-10-20. Applicant: Chase Mfg. Co..

Clearance details

Applicant: Chase Mfg. Co.
Product code: Code FCE
Advisory panel: Gastroenterology, Urology
Date received: 1977-09-22
Decision date: 1977-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.