510(k) K072908 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
| Applicant | Gambro Renal Products, Daytona Beach FL, US |
| Decision | Substantially Equivalent, Feb 4, 2008 |
| Received | Oct 12, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072908
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 24, 2016 | Baxter Healthcare Corp. PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.