510(k) K971571 ยท KDN System, Perfusion, Kidney
RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT
| Applicant | Waters Instruments, Inc., Rochester MN, US |
| Decision | Substantially Equivalent, Jul 29, 1997 |
| Received | Apr 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971571
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.