The following data is part of a premarket notification filed by The Surgical Company International with the FDA for Blood And Plasma Warming Devices.
| Device ID | BK050058 |
| 510k Number | BK050058 |
| Device Name: | Blood And Plasma Warming Devices |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | The Surgical Company International terminalweg 19a Amersfoort, 3821 AJ, NL |
| Product Code | KZL |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2006-05-05 |