510(k) K003957 ยท FIP Subsystem, Water Purification
DIACLEAR ULTRAFILTER
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Nov 1, 2001 |
| Received | Dec 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003957
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.