The following data is part of a premarket notification filed by Luvo Medical Technologies, Inc. with the FDA for Platelet And Plasma Separator For Bone Graft Handling.
| Device ID | BK210558 |
| 510k Number | BK210558 |
| Device Name: | Platelet And Plasma Separator For Bone Graft Handling |
| Classification | Platelet And Plasma Separator For Bone Graft Handling |
| Applicant | LUVO Medical Technologies, Inc. 125 Fleming Dr Cambridge, N1T 2B8, CANADA |
| 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 | 2021-03-04 |
| Decision Date | 2021-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00754016214127 | BK210558 | 0 |