510(k) K955497 ยท KDL Set, Perfusion, Kidney, Disposable
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET
| Applicant | Cobe Renal Care, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 25, 1997 |
| Received | Dec 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955497
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.