TANTALUM BEAD SET, MODEL P003175— 510(k) K090581

Name: FDA 510(k) clearance K090581
Creator: U.S. Food and Drug Administration
Published: 2009-08-21

Substantially Equivalent

Halifax Biomedical, Inc.

FDA 510(k) clearance K090581 for TANTALUM BEAD SET, MODEL P003175, Substantially Equivalent on 2009-08-21. Applicant: Halifax Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Halifax Biomedical, Inc.
Product code: Code NEU
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2009-03-03
Decision date: 2009-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundas, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code NEU

view all

More clearances from Halifax Biomedical, Inc.

view all

K182880 — Halifax Imaging Kit2018-10-31
K133966 — MODEL-BASED RSA SOFTWARE2014-03-06
K121345 — SR SUITE 1.02012-06-01
K103417 — HALIFAX BIOMEDICAL TANATLUM BEAD SET2011-06-28

Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.