510(k) K971428 ยท GGN Plasma, Coagulation Control
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
| Applicant | Pacific Hemostasis, Huntersville NC, US |
| Decision | Substantially Equivalent, Jun 17, 1997 |
| Received | Apr 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971428
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.