The following data is part of a premarket notification filed by Omrix Biopharmaceuticals Ltd. with the FDA for Evicel Application Device.
| Device ID | K090162 |
| 510k Number | K090162 |
| Device Name: | EVICEL APPLICATION DEVICE |
| Classification | Syringe, Piston |
| Applicant | OMRIX BIOPHARMACEUTICALS LTD. MDA BLOOD BANK SHEBA HOSPITAL, TEL HASHOMER Ramat Gan, IL 52621 |
| Contact | Sara Horn |
| Correspondent | Sara Horn 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-22 |
| Decision Date | 2009-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705031007239 | K090162 | 000 |
| 10705031007215 | K090162 | 000 |