The following data is part of a premarket notification filed by Suneva Medical, Inc. with the FDA for Platelet And Plasma Separator For Bone Graft Handling.
| Device ID | BK200477 |
| 510k Number | BK200477 |
| Device Name: | Platelet And Plasma Separator For Bone Graft Handling |
| Classification | Platelet And Plasma Separator For Bone Graft Handling |
| Applicant | Suneva Medical, Inc. 5870 Pacific Center Blvd San Diego, CA 92121 |
| 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 | 2020-04-10 |
| Decision Date | 2020-09-30 |