The following data is part of a premarket notification filed by Macoproductions S.a.s. with the FDA for Blood Transfusion Microfilters.
| Device ID | BK120071 |
| 510k Number | BK120071 |
| Device Name: | Blood Transfusion Microfilters |
| Classification | Microfilter, Blood Transfusion |
| Applicant | MacoProductions S.A.S. 3675 Crestwood Parkway suite 260 Duluth, GA 30096 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-06 |
| Decision Date | 2013-02-22 |