DIMIX CONTAINER FOR PARNETERAL NUTRIT— 510(k) K840915

Substantially Equivalent

Gil-Med Industries C/O Kegan & Kegan, Ltd.

FDA 510(k) clearance K840915 for DIMIX CONTAINER FOR PARNETERAL NUTRIT, Substantially Equivalent on 1984-04-17. Applicant: Gil-Med Industries C/O Kegan & Kegan, Ltd..

Clearance details

Applicant: Gil-Med Industries C/O Kegan & Kegan, Ltd.
Product code: Code KPE
Advisory panel: General Hospital
Date received: 1984-02-29
Decision date: 1984-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.