Fibrin Sealant Preparation Device
Fibrin Sealant Preparation Device
Omrix Biopharmaceuticals Ltd.
The following data is part of a premarket notification filed by Omrix Biopharmaceuticals Ltd. with the FDA for Fibrin Sealant Preparation Device.
Pre-market Notification Details
| Device ID | BK140093 |
| 510k Number | BK140093 |
| Device Name: | Fibrin Sealant Preparation Device |
| Classification | Fibrin Sealant Preparation Device |
| Applicant | Omrix Biopharmaceuticals Ltd. po Box 151, Route22 West Somerville, NJ 08876 |
| Product Code | MZM |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-02-12 |
| Decision Date | 2014-09-03 |
NIH GUDID Devices
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