The following data is part of a premarket notification filed by Arteriocyte Medical Systems, Inc with the FDA for Platelet And Plasma Separator For Bone Graft Handling.
| Device ID | BK200540 |
| 510k Number | BK200540 |
| Device Name: | Platelet And Plasma Separator For Bone Graft Handling |
| Classification | Platelet And Plasma Separator For Bone Graft Handling |
| Applicant | Arteriocyte Medical Systems, Inc 45 South Street, Suite 3 Hopkinton, MA 01748 |
| 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 | 2020-11-06 |
| Decision Date | 2022-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M896PRCSAP1201 | BK200540 | 0 |
| M896PRCDIA1201 | BK200540 | 0 |
| M896PRCDIA0600 | BK200540 | 0 |
| M896AMS500350560 | BK200540 | 0 |
| M896AMS500350530 | BK200540 | 0 |
| M896AMS500350500 | BK200540 | 0 |
| M896AMS500220560 | BK200540 | 0 |
| M896AMS500220530 | BK200540 | 0 |
| M896AMS500220500 | BK200540 | 0 |