510(k) K153670 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Genteel Lancing Device
| Applicant | Genteel, LLC, Midland TX, US |
| Decision | Substantially Equivalent, May 12, 2016 |
| Received | Dec 21, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153670
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.