The following data is part of a premarket notification filed by Macoproductions S.a.s. with the FDA for Blood Bank Supplies.
| Device ID | BK180306 |
| 510k Number | BK180306 |
| Device Name: | Blood Bank Supplies |
| Classification | Supplies, Blood-bank |
| Applicant | MacoProductions S.A.S. 200 Chaussee Fernand Forest Tourcoing, 59200, FR |
| Product Code | KSS |
| CFR Regulation Number | 864.9050 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-27 |
| Decision Date | 2019-01-24 |