510(k) K002045 ยท FIP Subsystem, Water Purification
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
| Applicant | Total Water Treatment Systems, Inc., Madison WI, US |
| Decision | Substantially Equivalent, Feb 16, 2001 |
| Received | Jul 5, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002045
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.