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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 BK030022
Tradename Fresenius Compomat G4 & Compomaster NT
Device Name Supplies, Blood-Bank
Original Applicant
Fresenius Medical Care North America
6675 185th avenue ne
suite 100
redmond,  WA  98052
Regulation Number864.9050
Classification Product Code
KSS  
Date Received03/14/2003
Decision Date 07/11/2003
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
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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