510(k) K820304 ยท FJI Dialyzer, Capillary, Hollow Fiber
GAMBRO GF-80-M, GF-80-H HEMODIALYZER
| Applicant | Gambro, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 2, 1982 |
| Received | Feb 4, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K820304
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.