The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Platelet Separation/concentration System.
| Device ID | BK040068 |
| 510k Number | BK040068 |
| Device Name: | Platelet Separation/Concentration System |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 US |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-31 |
| Decision Date | 2004-11-09 |