The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for Venoject Luer Adapter.
| Device ID | K041358 |
| 510k Number | K041358 |
| Device Name: | VENOJECT LUER ADAPTER |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | TERUMO EUROPE N.V. 125 Blue Ball Road Elkton, MD 21921 |
| Contact | Sandi Hartka |
| Correspondent | Sandi Hartka TERUMO EUROPE N.V. 125 Blue Ball Road Elkton, MD 21921 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-21 |
| Decision Date | 2004-05-28 |
| Summary: | summary |