The following data is part of a premarket notification filed by Owen Mumford Usa, Inc. with the FDA for Autoject Mini.
| Device ID | K953735 |
| 510k Number | K953735 |
| Device Name: | AUTOJECT MINI |
| Classification | Introducer, Syringe Needle |
| Applicant | OWEN MUMFORD USA, INC. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 |
| Contact | Robert Shaw |
| Correspondent | Robert Shaw OWEN MUMFORD USA, INC. 849 PICKENS INDUSTRIAL DR. SUITE 14 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 | 1995-08-10 |
| Decision Date | 1995-11-08 |