510(k) K062435 ยท NFK Kit, Repair, Catheter, Hemodialysis
REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
| Applicant | Spire Biomedical, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Dec 5, 2006 |
| Received | Aug 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062435
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.