510(k) K902564 ยท FIE Needle, Fistula
NEEDLE, DIALYSIS
| Applicant | Gainor Medical Europe, Ltd., Mcdonough GA, US |
| Decision | Substantially Equivalent, Mar 1, 1991 |
| Received | Jun 11, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K902564
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.