The following data is part of a premarket notification filed by Owen Mumford Ltd with the FDA for Unistik Touch Single-use Safety Lancets - 16g, 21g, 23g, 28g And 30g.
| Device ID | K222111 |
| 510k Number | K222111 |
| Device Name: | Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G And 30G |
| Classification | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| 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 | FMK |
| CFR Regulation Number | 878.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-18 |
| Decision Date | 2022-09-07 |