510(k) K090162 ยท FMF Syringe, Piston
EVICEL APPLICATION DEVICE
| Applicant | Omrix Biopharmaceuticals , Ltd., Ramat Gan, IL |
| Decision | Substantially Equivalent, Feb 20, 2009 |
| Received | Jan 22, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090162
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2012 | Ethicon, Inc. EVICEL Fibrin Sealant (Human) Rx Only.
Manufacturer:
Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603.
Distributed Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.