EZ-JECT— 510(k) K051667

Substantially Equivalent

Indolor, Ltd.

FDA 510(k) clearance K051667 for EZ-JECT, Substantially Equivalent on 2005-09-27. Applicant: Indolor, Ltd..

Clearance details

Applicant: Indolor, Ltd.
Product code: Code KZH
Advisory panel: General Hospital
Date received: 2005-06-22
Decision date: 2005-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.