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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK190413
Tradenames CompoMaster Net G5 Plus, CompoMat G5 Plus
Device Name Supplies, Blood-Bank
Original Applicant
Fresenius Kabi AG
else-kroner-strasse 1
Bad Homburg,  61352,  GERMANY
Regulation Number864.9050
Classification Product Code
KSS  
Date Received11/12/2019
Decision Date 02/06/2020
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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