510(k) K222168 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
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
| Applicant | Owen Mumford, Ltd., Woodstock, GB |
| Decision | Substantially Equivalent, Nov 3, 2022 |
| Received | Jul 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222168
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.