The following data is part of a premarket notification filed by Regenlab Sa with the FDA for Peripheral Blood Processing Device For Wound Management.
| Device ID | BK210661 |
| 510k Number | BK210661 |
| Device Name: | Peripheral Blood Processing Device For Wound Management |
| Classification | Peripheral Blood Processing Device For Wound Management |
| Applicant | RegenLab SA en Budron B2 ch-1052 Le Mont Sur Lausanne SWITZERLAND |
| Product Code | PMQ |
| CFR Regulation Number | 864.9245 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-17 |
| Decision Date | 2022-07-08 |