510(k) K030032 ยท FMI Needle, Hypodermic, Single Lumen
CROSSEAL APPLICATION DEVICE
| Applicant | Omrix Biopharmaceuticals, Inc., Warrington VA, US |
| Decision | Substantially Equivalent, Mar 21, 2003 |
| Received | Jan 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030032
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2004 | Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst. Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.