The following data is part of a premarket notification filed by Owen Mumford Usa, Inc. with the FDA for Autoject 2.
| Device ID | K013362 |
| 510k Number | K013362 |
| Device Name: | AUTOJECT 2 |
| Classification | Introducer, Syringe Needle |
| Applicant | OWEN MUMFORD USA, INC. 1755-A WEST OAK COMMONS CT. Marietta, GA 30062 |
| Contact | Robert Shaw |
| Correspondent | Robert Shaw OWEN MUMFORD USA, INC. 1755-A WEST OAK COMMONS CT. Marietta, GA 30062 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-10 |
| Decision Date | 2001-11-13 |
| Summary: | summary |