The following data is part of a premarket notification filed by Ranfac Corporation with the FDA for Platelet And Plasma Separator For Bone Graft Handling.
| Device ID | BK200543 |
| 510k Number | BK200543 |
| Device Name: | Platelet And Plasma Separator For Bone Graft Handling |
| Classification | Platelet And Plasma Separator For Bone Graft Handling |
| Applicant | Ranfac Corporation 30 Doherty St Avon, MA 02322 |
| 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 | 2020-11-13 |
| Decision Date | 2021-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850023741308 | BK200543 | 000 |
| 10850023741896 | BK200543 | 000 |
| 00850023741936 | BK200543 | 000 |
| 10850023741919 | BK200543 | 000 |
| 10850023741797 | BK200543 | 000 |
| 00850023741653 | BK200543 | 000 |
| 00850023741660 | BK200543 | 000 |
| 10857878007405 | BK200543 | 000 |
| 10857878007474 | BK200543 | 000 |
| 10858690006553 | BK200543 | 000 |
| 10858690006584 | BK200543 | 000 |
| 10858690006683 | BK200543 | 000 |
| 10858690006799 | BK200543 | 000 |
| 10850023741544 | BK200543 | 000 |
| 10850023741278 | BK200543 | 000 |
| 10850023741988 | BK200543 | 000 |