510(k) K070575 ยท FMF Syringe, Piston
EVICEL APPLICATION DEVICE
| Applicant | Omrix Biopharmaceuticals , Ltd., Ramat Gan, IL |
| Decision | Substantially Equivalent, May 29, 2007 |
| Received | Feb 28, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070575
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2018 | Ethicon, Inc. Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device. Terminated |
FMF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.