510(k) K193155 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Nipro Dry Complete Dry Acid Concentrate for Hemodialysis
| Applicant | Nipro Renal Solutions USA, Corp., Lewisberry PA, US |
| Decision | Substantially Equivalent, Nov 25, 2020 |
| Received | Nov 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193155
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.