510(k) K031554 ยท CAC Apparatus, Autotransfusion
S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
| Applicant | Genzyme Biosurgery, Fall River MA, US |
| Decision | Substantially Equivalent, Jul 25, 2003 |
| Received | May 19, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031554
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.