The following data is part of a premarket notification filed by Owen Mumford, Ltd. with the FDA for Modification To Autoject Mini.
| Device ID | K000482 |
| 510k Number | K000482 |
| Device Name: | MODIFICATION TO AUTOJECT MINI |
| Classification | Introducer, Syringe Needle |
| Applicant | OWEN MUMFORD, LTD. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 -3165 |
| Contact | Robert Shaw |
| Correspondent | Robert Shaw OWEN MUMFORD, LTD. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 -3165 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-14 |
| Decision Date | 2000-03-06 |