510(k) K050827 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)
| Applicant | Dialysis Solutions, Inc., Lincolnshire IL, US |
| Decision | Substantially Equivalent, Aug 22, 2005 |
| Received | Apr 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050827
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.