Safety Plus
FDA 510(k) K945843 · Arent Fox
510(k) numberK945843
Submission
- Device name
- Safety Plus
- Applicant
- Arent Fox
Washington, DC, US - Received
- November 30, 1994
- Decision date
- July 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EJI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171254 | LeEject 2 Dental Syringe and Needle SystemEJI · Traditional | Advanced Technology and Capital, Inc. | 11/16/2017SE |
| K142414 | Miltex N-Tralig Intraligamentary SyringeEJI · Special | Integra LifeSciences Corporation | 10/30/2014SE |
| K120659 | Hu-Friedy Dental Cartridge SyringeEJI · Traditional | Hu-Friedy Mfg. Co., LLC | 11/06/2012SE |
| K113247 | Anesthesia Injection Tool SetEJI · Traditional | Ki Works Co., Ltd. | 03/27/2012SE |
| K082249 | MorpheusEJI · Abbreviated | Meibach Tech Ltda | 12/31/2009SE |
| K092943 | Aspirating Syringe, Non-Aspirating SyringeEJI · Traditional | Arnold Tuber Industries | 12/11/2009SE |
| K083796 | Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating…EJI · Traditional | Miltex, Inc. | 03/09/2009SE |
| K081694 | DenjectorEJI · Traditional | Dxm Co., Ltd. | 09/12/2008SE |
| K061904 | Compudent StaEJI · Traditional | Milestone Scientific, Inc. | 08/08/2006SE |
| K043322 | Miramatic Safe Syringe SystemEJI · Traditional | Hager Worldwide, Inc. | 07/21/2005SE |
More from Hager Worldwide, Inc.
Questions and answers
When was Safety Plus cleared by the FDA?
Safety Plus (K945843) received a 510(k) decision of Substantially Equivalent on July 11, 1995, 223 days after the submission was received.
What is the product code of K945843?
The FDA product code is EJI – Syringe, Cartridge, a Class II (moderate risk) device regulated under 21 CFR 872.6770.