The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Henke-ject Pressure Syringe (modification).
| Device ID | K864294 |
| 510k Number | K864294 |
| Device Name: | HENKE-JECT PRESSURE SYRINGE (MODIFICATION) |
| Classification | Injector, Jet, Mechanical-powered |
| Applicant | SMITH & NEPHEW, INC. 1820 W. ROSCOE ST. Chicago, IL 60657 |
| Contact | Thomas F Willer |
| Correspondent | Thomas F Willer SMITH & NEPHEW, INC. 1820 W. ROSCOE ST. Chicago, IL 60657 |
| Product Code | EGM |
| CFR Regulation Number | 872.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-31 |
| Decision Date | 1987-11-04 |