510(k) K912111 ยท FMF Syringe, Piston
MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE
| Applicant | Gerard Medical Enterprises, Inc., Brimfield MA, US |
| Decision | Substantially Equivalent, Oct 8, 1991 |
| Received | May 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912111
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.