The following data is part of a premarket notification filed by Owen Mumford Ltd with the FDA for Unifine Safecontrol 5mm X 30g, Unifine Safecontrol 8mm X 30g.
| Device ID | K173881 |
| 510k Number | K173881 |
| Device Name: | Unifine SafeControl 5mm X 30G, Unifine SafeControl 8mm X 30G |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Owen Mumford Ltd Brook Hill Woodstock, GB Ox20 1tu |
| Contact | Darren Mansell |
| Correspondent | Patty Cronan Owen Mumford USA Inc 1755 West Oak Commons CT Marietta, CA 30062 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-21 |
| Decision Date | 2018-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384707955000 | K173881 | 000 |
| 00384707935026 | K173881 | 000 |
| 00384700935238 | K173881 | 000 |