The following data is part of a premarket notification filed by Omrix Biopharmaceuticals Ltd. with the FDA for Evicel Application Device.
| Device ID | K070575 |
| 510k Number | K070575 |
| Device Name: | EVICEL APPLICATION DEVICE |
| Classification | Syringe, Piston |
| Applicant | OMRIX BIOPHARMACEUTICALS LTD. MDA BLOOD BANK SHEBA HOSPITAL, TEL HASHOMER Ramat Gan, IL 52621 |
| Contact | David Nakar |
| Correspondent | David Nakar OMRIX BIOPHARMACEUTICALS LTD. MDA BLOOD BANK SHEBA HOSPITAL, TEL HASHOMER Ramat Gan, IL 52621 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-28 |
| Decision Date | 2007-05-29 |