510(k) K002816 ยท KOC Accessories, Blood Circuit, Hemodialysis
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
| Applicant | Transonic Systems, Inc., Ithaca NY, US |
| Decision | Substantially Equivalent, Nov 22, 2000 |
| Received | Sep 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002816
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.