SAFE-T-CAP NEEDLE COVER— 510(k) K896219

Substantially Equivalent

Ausmedics Pty , Ltd.

FDA 510(k) clearance K896219 for SAFE-T-CAP NEEDLE COVER, Substantially Equivalent on 1990-01-22. Applicant: Ausmedics Pty , Ltd..

Clearance details

Applicant: Ausmedics Pty , Ltd.
Product code: Code DZM
Advisory panel: Dental
Date received: 1989-10-27
Decision date: 1990-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZM

product code DZM

Injury: 139
Total: 139

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.