510(k) K193009 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Promisemed Heel Blood Lancet
| Applicant | Promisemed Hangzhou Meditech Co., Ltd., Hangzhou City, CN |
| Decision | Substantially Equivalent, Dec 3, 2019 |
| Received | Oct 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193009
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.