510(k) K911777 ยท GGN Plasma, Coagulation Control
ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Aug 22, 1991 |
| Received | Apr 2, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911777
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.