Blood Transfusion Microfilters
Microfilter, Blood Transfusion
MacoProductions S.A.S.
The following data is part of a premarket notification filed by Macoproductions S.a.s. with the FDA for Blood Transfusion Microfilters.
Pre-market Notification Details
| Device ID | BK030008 |
| 510k Number | BK030008 |
| Device Name: | Blood Transfusion Microfilters |
| Classification | Microfilter, Blood Transfusion |
| Applicant | MacoProductions S.A.S. c/o Hoppe Regulatory Consultants 2335 Massey Lane Decatur, GA 30033 US |
| 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 | 2003-02-05 |
| Decision Date | 2003-05-02 |
NIH GUDID Devices
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