510(k) K042797 ยท FIP Subsystem, Water Purification
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Mar 9, 2005 |
| Received | Oct 8, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K042797
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.