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 |
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 |
10850023741896 | BK200543 | 000 |