The following data is part of a premarket notification filed by Terumo Bct, Inc with the FDA for Platelet And Plasma Separator For Bone Graft Handling.
| Device ID | BK210591 |
| 510k Number | BK210591 |
| Device Name: | Platelet And Plasma Separator For Bone Graft Handling |
| Classification | Platelet And Plasma Separator For Bone Graft Handling |
| Applicant | Terumo BCT, Inc 10811 W. Collins Ave. Lakewood, CO 80215 |
| Product Code | ORG |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-21 |
| Decision Date | 2022-02-11 |