510(k) K013448 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
PRISMASATE
| Applicant | Gambro Renal Products, Daytona Beach FL, US |
| Decision | Substantially Equivalent, Jan 15, 2002 |
| Received | Oct 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013448
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.