510(k) K984546 ยท FLD Apparatus, Hemoperfusion, Sorbent
BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK
| Applicant | Hemocleanse, Inc., West Lafayette IN, US |
| Decision | Substantially Equivalent, Aug 13, 1999 |
| Received | Dec 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984546
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.