510(k) K911997 ยท FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
TENDERFOOT(R), MODIFICATION
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Jul 17, 1991 |
| Received | Apr 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911997
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.