The following data is part of a premarket notification filed by Sarstedt, Inc. with the FDA for Blood And Plasma Warming Devices.
| Device ID | BK010045 |
| 510k Number | BK010045 |
| 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 | 2001-10-29 |
| Decision Date | 2001-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04028339710939 | BK010045 | 0 |
| 04028339710236 | BK010045 | 0 |
| 04038917968645 | BK010045 | 000 |
| 04038917968324 | BK010045 | 000 |