The following data is part of a premarket notification filed by Smith & Nephew, Mpl Division with the FDA for Henke Ject Pressure Syringe.
| Device ID | K830524 |
| 510k Number | K830524 |
| Device Name: | HENKE JECT PRESSURE SYRINGE |
| Classification | Syringe, Cartridge |
| Applicant | SMITH & NEPHEW, MPL DIVISION 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-17 |
| Decision Date | 1983-03-24 |