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Blood Establishment Computer Software And Accessories

MAK-SYSTEM SA International Group

The following data is part of a premarket notification filed by Mak-system Sa International Group with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

Device IDBK180232
510k NumberBK180232
Device Name:510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
ClassificationBlood Establishment Computer Software And Accessories
Applicant MAK-SYSTEM SA International Group 10 Avenue De La Grande-armee Paris,  75017,  FR
Product CodeMMH  
CFR Regulation Number864.9165 [🔎]
DecisionSubstantially Equivalent (SE)
Type510(k) Traditio
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-20
Decision Date2018-10-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03665324000005 BK180232 0

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