Data / Medical devices / United States / THE HIBBERT GROUP - Corp Center
THE HIBBERT GROUP - Corp Center: FDA-registered device maker in Hamilton, NJ, United States, 1 510(k) clearance
THE HIBBERT GROUP - Corp Center is registered with the FDA (registration 3001728571) in Hamilton, NJ, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 19, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001728571
- Address
- 400 Pennington Ave, Hamilton, NJ, United States, 08650
- Owner or operator
- The Hibbert Group (10028889)
- Roles
- Repackager or relabeler
- First device listed
- March 17, 2009
- Registered through
- 2026
- Brand names listed
- BD Nano 2nd Gen Pen Needle, Nano, Nano 2nd Gen
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 19, 2021 | K212015 | BD Nano 2nd Gen Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
Compare with other makers
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Needle, Aspiration And Injection, Disposable
Updated November 19, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.