510(k) K221778 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Disposable Safety Lancets
| Applicant | Suzhou Kyuan Medical Apparatus Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Oct 3, 2022 |
| Received | Jun 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221778
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.