The following data is part of a premarket notification filed by Sarstedt, Inc. with the FDA for Blood And Plasma Warming Devices.
| Device ID | BK040080 |
| 510k Number | BK040080 |
| Device Name: | Blood And Plasma Warming Devices |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | Sarstedt, Inc. 1025 Saint James Church Rd. Newton, NC 20865 US |
| Product Code | KZL |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Abbrevia |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-22 |
| Decision Date | 2005-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04028339720235 | BK040080 | 0 |
| 04038917968560 | BK040080 | 000 |