510(k) K001059 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
NORMOCARB STERILE BICARBONATE RENAL DIALYSIS
| Applicant | Novex Pharma, Richmond Hill, Ontario, CA |
| Decision | Substantially Equivalent, Jun 30, 2000 |
| Received | Apr 3, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001059
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.