510(k) K972627 ยท GJT Plasma, Coagulation Factor Deficient
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)
| Applicant | Pacific Hemostasis, Huntersville NC, US |
| Decision | Substantially Equivalent, Aug 13, 1997 |
| Received | Jul 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972627
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.