510(k) K993385 ยท KZH Introducer, Syringe Needle
AUTOJET 2 (NON-FIXED NEEDLE TYPE)
| Applicant | Owen Mumford USA, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Nov 10, 1999 |
| Received | Oct 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993385
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.