510(k) K220643 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets
| Applicant | Htl-Strefa S.A, Ozorkow, PL |
| Decision | Substantially Equivalent, Jul 8, 2022 |
| Received | Mar 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220643
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.