The following data is part of a premarket notification filed by Owen Mumford Ltd with the FDA for Unifine Safecontrol.
| Device ID | K210399 |
| 510k Number | K210399 |
| Device Name: | Unifine SafeControl |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Owen Mumford Ltd Brook Hill Woodstock, GB Ox20 1tu |
| Contact | Darren Mansell |
| Correspondent | Darren Mansell Owen Mumford Ltd Brook Hill Woodstock, GB Ox20 1tu |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-10 |
| Decision Date | 2021-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384704190039 | K210399 | 000 |
| 00384704150033 | K210399 | 000 |
| 00384704140034 | K210399 | 000 |
| 00384704130035 | K210399 | 000 |
| 00384700140229 | K210399 | 000 |
| 00384700190224 | K210399 | 000 |
| 00384700150228 | K210399 | 000 |
| 00384707940020 | K210399 | 000 |