The following data is part of a premarket notification filed by Macoproductions S.a.s. with the FDA for Blood Transfusion Microfilters.
Device ID | BK050041 |
510k Number | BK050041 |
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 | 2005-07-25 |
Decision Date | 2005-10-12 |