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 IDBK050041
510k NumberBK050041
Device Name:Blood Transfusion Microfilters
ClassificationMicrofilter, Blood Transfusion
Applicant MacoProductions S.A.S. c/o Hoppe Regulatory Consultants 2335 Massey Lane Decatur,  GA  30033 US
Product CodeCAK  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-25
Decision Date2005-10-12

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