Pre-market Notification Details
| Device ID | BK040076 |
| 510k Number | BK040076 |
| Device Name: | Transfer Sets |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | Fresenius Medical Care North America 95 Hayden Avenue Lexington, MA 02420 US |
| Product Code | KSB |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-13 |
| Decision Date | 2004-12-17 |
NIH GUDID Devices
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.