510(k) K011368 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS
| Applicant | Gambro Renal Products, Daytona Beach FL, US |
| Decision | Substantially Equivalent, Aug 2, 2001 |
| Received | May 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011368
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.