The following data is part of a premarket notification filed by Owen Mumford, Ltd. with the FDA for Autoject 2 For Glassy Syringe.
| Device ID | K122837 |
| 510k Number | K122837 |
| Device Name: | AUTOJECT 2 FOR GLASSY SYRINGE |
| Classification | Introducer, Syringe Needle |
| Applicant | OWEN MUMFORD, LTD. BROOK HILL Woodstock, Oxfordshire, GB 0x20itu |
| Contact | Darren Mansell |
| Correspondent | Darren Mansell OWEN MUMFORD, LTD. BROOK HILL Woodstock, Oxfordshire, GB 0x20itu |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-17 |
| Decision Date | 2012-10-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15016189106015 | K122837 | 000 |