510(k) K233159 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA, US |
| Decision | Substantially Equivalent, Dec 1, 2023 |
| Received | Sep 27, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233159
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.