The following data is part of a premarket notification filed by Owen Mumford Ltd with the FDA for Unistik Tinytouch Sterile Single-use Heel Incision Safety Lancets - Preemie And Full-term, Unistik Heelstik Sterile Single-use Heel Incision Safety Lancets - Micropreemie, Preemie, Full-term And Toddler.
| Device ID | K222168 |
| 510k Number | K222168 |
| Device Name: | Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie And Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term And Toddler |
| 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 | 2022-07-21 |
| Decision Date | 2022-11-03 |