510(k) K923302 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
TENDERLETT FINGER
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Jan 22, 1993 |
| Received | Jul 6, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923302
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2006 | International Technidyne Corp Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use. Terminated |
FMK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.