The following data is part of a premarket notification filed by Owen Mumford Usa, Inc. with the FDA for Autoject 2.
| Device ID | K945660 |
| 510k Number | K945660 |
| Device Name: | AUTOJECT 2 |
| Classification | Introducer, Syringe Needle |
| Applicant | OWEN MUMFORD USA, INC. 849 PICKENS INDUSTRIAL DR. SUITE 14 Marietta, GA 30062 |
| Contact | Robert E Shaw |
| Correspondent | Robert E 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 | 1994-11-17 |
| Decision Date | 1995-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384703310018 | K945660 | 000 |
| 00384701310010 | K945660 | 000 |
| 00384701300011 | K945660 | 000 |