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 |