510(k) K091978 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
DBB-06 HEMODIALYSIS DELIVERY SYSTEM
| Applicant | NIKKISO CO., LTD., Tokyo, JP |
| Decision | Substantially Equivalent, Mar 25, 2010 |
| Received | Jul 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091978
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 24, 2021 | Nikkiso Ltd - Shizuoka Plant DBB-06 Hemodialysis Delivery System Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.